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510(k) Data Aggregation

    K Number
    K965158
    Device Name
    HEART PROTECTOR (VER 1996)
    Manufacturer
    N.P.N.T., INC.
    Date Cleared
    1997-12-09

    (351 days)

    Product Code
    DRT
    Regulation Number
    870.2300
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To be used before, during and after exercise. To be used while at rest. The primary function is as a Heart Tachometer. The user also can be alerted if various presets have been exceeded.

    Device Description

    Not Found

    AI/ML Overview

    This appears to be an FDA 510(k) clearance letter from 1997 for a device called "Heart Protector". This document primarily focuses on the regulatory clearance of a device based on substantial equivalence to a predicate device, rather than providing a detailed study report with specific acceptance criteria and performance metrics.

    Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies cannot be extracted from the provided text.

    The document only states the device's indications for use: "To be used before, during and after exercise. To be used while at rest. The primary function is as a Heart Tachometer. The user also can be alerted if various presets have been exceeded."

    To answer your questions, a separate study report or regulatory submission would be required.

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