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510(k) Data Aggregation

    K Number
    K993460
    Device Name
    ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z43
    Manufacturer
    ROSSMAX INTERNATIONAL LTD.
    Date Cleared
    2000-01-11

    (90 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z43

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To measure systolic and diastolic blood pressure and heart rate on the wrist using the oscillometric method. Limited to patient over 18 years and wrist circumference between 5.3 to 7.7 inches.

    Device Description

    Rossmax Automatic Wristwatch Blood Pressure Monitor, model ZA3

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the "Rossmax Automatic Wristwatch Blood Pressure Monitors, Z-series." It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information based on the given input.

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