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510(k) Data Aggregation

    K Number
    K042505
    Device Name
    OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N
    Manufacturer
    OMRON HEALTHCARE, INC.
    Date Cleared
    2005-04-05

    (202 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    K092163,K120430,K122482,K123498,K131742,K131749
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 1/4 inches to 8 1/2 inches (13.5 cm to 21.5 cm).

    The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

    Device Description

    Not Found

    AI/ML Overview

    This redacted FDA 510(k) summary only includes the formal letter approving the device for market, the device's indications for use, and a cover sheet. It does NOT contain any information about acceptance criteria or a study proving the device meets acceptance criteria. Therefore, I cannot provide the requested information.

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