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510(k) Data Aggregation

    K Number
    K991458
    Device Name
    MECA WRIST BLOOD PRESSURE METER, MODEL EW243 AND MODEL EW254
    Date Cleared
    2000-04-10

    (350 days)

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

    MATSUSHITA ELECTRIC CORP. OF AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Model EW243 and model EW254 are intended to be used for the oscillometric PRECISE LOGIC™ measurement of systolic and diastolic blood pressure and pulse rate using a pressurized cuff. These devices are designed for use by adults. These devices should not be used on infants or toddlers, for continuous monitoring medical emergencies or operations, or for any other purpose other than measuring blood pressure. Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultation method, within the limits prescribed by the American National Standard, Electronic or Automated Sphygmomanometers.
    Device Description
    MECA intends to market two battery-operated, non-invasive, digital, electronic, arm blood pressure monitors, model EW243 and model EW254.
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