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510(k) Data Aggregation

    K Number
    K964153

    Validate with FDA (Live)

    Device Name
    ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4000
    Manufacturer
    ROSSMAX INTERNATIONAL LTD.
    Date Cleared
    1998-06-11

    (603 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

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

    Device Description

    Not Found

    AI/ML Overview

    This looks like a 510(k) clearance letter from the FDA for a blood pressure monitor, not a study evaluating an AI/ML device. Therefore, the requested information about acceptance criteria, study details, and AI-specific metrics is not present in the provided document.

    To answer your request, I would need a document describing a study conducted to prove the performance of an AI/ML device against specific acceptance criteria.

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