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  "name": "Nihon Kohden America Inc",
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    "last12Months": 0,
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    "latest": "2012-03-22"
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  "productCodeCount": 36,
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    "openLast12Months": 0,
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        "resNumber": "Z-0267-2025",
        "productCode": "DQA",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2024-09-18",
        "reason": "Due to oximeters not having FDA market approval or clearance to distribute in the U.S."
      },
      {
        "resNumber": "Z-0268-2025",
        "productCode": "DQA",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2024-09-18",
        "reason": "Due to oximeters not having FDA market approval or clearance to distribute in the U.S."
      },
      {
        "resNumber": "Z-2025-2024",
        "productCode": "MHX",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2024-04-29",
        "reason": "Due to software issue the device may give false \"SpO2 Probe Failure\" alarm"
      },
      {
        "resNumber": "Z-0314-2025",
        "productCode": "CCK",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2022-04-29",
        "reason": "Due to products being shipped/distributed to customers after the products expiration date had past."
      },
      {
        "resNumber": "Z-1162-2021",
        "productCode": "DRG",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2021-01-08",
        "reason": "Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter."
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    "countries": [
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      "code": "DSI",
      "deviceName": "Detector And Alarm, Arrhythmia",
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      "latest": "2001-02-08",
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    {
      "code": "GWQ",
      "deviceName": "Full-Montage Standard Electroencephalograph",
      "clearances": 15,
      "latest": "2012-03-22",
      "medianReviewDays": 75
    },
    {
      "code": "MHX",
      "deviceName": "Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)",
      "clearances": 11,
      "latest": "2008-12-24",
      "medianReviewDays": 84
    },
    {
      "code": "DRT",
      "deviceName": "Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)",
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      "latest": "2005-02-03",
      "medianReviewDays": 90
    },
    {
      "code": "CCK",
      "deviceName": "Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase",
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      "latest": "2009-03-02",
      "medianReviewDays": 151
    },
    {
      "code": "OLV",
      "deviceName": "Standard Polysomnograph With Electroencephalograph",
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      "latest": "2008-01-11",
      "medianReviewDays": 59
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    {
      "code": "LDD",
      "deviceName": "Dc-Defibrillator, Low-Energy, (Including Paddles)",
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      "latest": "1997-10-21",
      "medianReviewDays": 95
    },
    {
      "code": "GWF",
      "deviceName": "Stimulator, Electrical, Evoked Response",
      "clearances": 7,
      "latest": "2008-10-06",
      "medianReviewDays": 112
    },
    {
      "code": "DQA",
      "deviceName": "Oximeter",
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      "latest": "2000-01-07",
      "medianReviewDays": 150
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    {
      "code": "DRG",
      "deviceName": "Transmitters And Receivers, Physiological Signal, Radiofrequency",
      "clearances": 5,
      "latest": "2007-06-29",
      "medianReviewDays": 154
    },
    {
      "code": "BZQ",
      "deviceName": "Monitor, Breathing Frequency",
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      "latest": "1989-10-24",
      "medianReviewDays": 218
    },
    {
      "code": "DXG",
      "deviceName": "Computer, Diagnostic, Pre-Programmed, Single-Function",
      "clearances": 3,
      "latest": "1987-02-19",
      "medianReviewDays": 17
    },
    {
      "code": "DXJ",
      "deviceName": "Display, Cathode-Ray Tube, Medical",
      "clearances": 3,
      "latest": "1988-11-09",
      "medianReviewDays": 80
    },
    {
      "code": "GWL",
      "deviceName": "Amplifier, Physiological Signal",
      "clearances": 3,
      "latest": "1988-09-30",
      "medianReviewDays": 196
    },
    {
      "code": "DPW",
      "deviceName": "Flowmeter, Blood, Cardiovascular",
      "clearances": 2,
      "latest": "1990-01-19",
      "medianReviewDays": 28
    },
    {
      "code": "DRS",
      "deviceName": "Transducer, Blood-Pressure, Extravascular",
      "clearances": 2,
      "latest": "1984-04-17",
      "medianReviewDays": 70
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    {
      "code": "DSF",
      "deviceName": "Recorder, Paper Chart",
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      "latest": "1988-07-14",
      "medianReviewDays": 76
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    {
      "code": "DXN",
      "deviceName": "System, Measurement, Blood-Pressure, Non-Invasive",
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      "medianReviewDays": 70
    },
    {
      "code": "GWE",
      "deviceName": "Stimulator, Photic, Evoked Response",
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      "latest": "1984-11-09",
      "medianReviewDays": 94
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    {
      "code": "GWK",
      "deviceName": "Conditioner, Signal, Physiological",
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      "latest": "1991-06-28",
      "medianReviewDays": 58
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    {
      "code": "GYB",
      "deviceName": "Media, Electroconductive",
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      "latest": "1986-11-13",
      "medianReviewDays": 114
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    {
      "code": "IKN",
      "deviceName": "Electromyograph, Diagnostic",
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      "latest": "2001-06-28",
      "medianReviewDays": 43
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    {
      "code": "IKT",
      "deviceName": "Electrode, Needle, Diagnostic Electromyograph",
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    {
      "code": "OMA",
      "deviceName": "Amplitude-Integrated Electroencephalograph",
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      "latest": "2012-03-16",
      "medianReviewDays": 28
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  "productCodesTotal": "36",
  "recentClearances": [
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      "kNumber": "K113117",
      "deviceName": "NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX",
      "productCode": "GWQ",
      "decisionDate": "2012-03-22",
      "reviewDays": 153
    },
    {
      "kNumber": "K120485",
      "deviceName": "NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P",
      "productCode": "OMA",
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    {
      "kNumber": "K092573",
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    {
      "kNumber": "K083456",
      "deviceName": "NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P",
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    {
      "kNumber": "K083271",
      "deviceName": "BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY",
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    {
      "kNumber": "K082785",
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      "kNumber": "K071969",
      "deviceName": "SEN-4100 ELECTRIC STIMULATOR",
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      "decisionDate": "2008-10-06",
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    {
      "kNumber": "K080546",
      "deviceName": "NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A",
      "productCode": "OLT",
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      "reviewDays": 183
    },
    {
      "kNumber": "K073550",
      "deviceName": "PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION",
      "productCode": "MHX",
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    {
      "kNumber": "K080342",
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      "productCode": "MHX",
      "decisionDate": "2008-02-26",
      "reviewDays": 18
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        "method": "normalised"
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