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510(k) Data Aggregation

    K Number
    K042818
    Device Name
    PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW3003 AND EW3037
    Date Cleared
    2005-01-27

    (107 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    MATSUSHITA ELECTRIC WORKS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Panasonic Wrist Blood Pressure Monitor, Models EW 3003 and EW 3037 are devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. For the EW 3037, display of Normal (green), Prehypertensive (yellow) or Hypertensive (orange) are based on blood pressure values classified in the paper: "JNC Express, The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure", U.S. Department of Health and Human Services, National Institutes of Health, National Heart, Lung, and Blood Pressure Institute, National High Blood Pressure Education Program, NIH Publication No 03-5233, May 2003. The display values are generally known, but not proven, to be an indicator of your blood pressure. The EW 3037 is not intended to be a diagnostic device. Contact your physician if prehypertensive or hypertensive values are indicated.
    Device Description
    Panasonic Wrist Blood Pressure Monitor Models EW3003 and EW3037
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    K Number
    K033894
    Device Name
    PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW 3031 AND EW 3032
    Date Cleared
    2004-03-11

    (86 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    MATSUSHITA ELECTRIC WORKS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Panasonic Wrist Blood Pressure Monitor, Models EW 3031 and EW 3032 are devices intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. For the EW 3032, display of Normal (green), Prehypertensive (yellow) or Hypertensive (orange) are based on blood pressure values classified in the paper: "JNC Express, The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure" , U.S. Department of Health and Human Services, National Institutes of Health, National Heart, Lung, and Blood Pressure Institute, National High Blood Pressure Education Program, NIH Publication No 03-5233, May 2003. The display values are generally known, but not proven, to be an indicator of your blood pressure. The EW 3032 is not intended to be a diagnostic device. Contact your physician if prehypertensive or hypertensive values are indicated.
    Device Description
    The Panasonic Wrist Blood Pressure Monitor, Models 3031/3032 are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic capacitive pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".
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