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510(k) Data Aggregation

    K Number
    K010828
    Device Name
    DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP
    Manufacturer
    A & D ENGINEERING, INC.
    Date Cleared
    2001-03-29

    (9 days)

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

    DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP

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

    The A&D Medical LifeSource TM-2655, TM-2655P & TM-2655VP are designed to measure blood pressure (diastolic & systolic) and pulse rate in adult patients with arm circumferences from 5.1 inches (13.0 cm) to 17.7 inches (45.0 cm).

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for A&D Engineering Inc.'s Digital Blood Pressure Monitors. Unfortunately, the provided text does not contain the detailed acceptance criteria or the specifics of a study proving the device meets those criteria.

    The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It refers to "indications for use" and "general controls provisions of the Act," but does not elaborate on the specific performance metrics or studies used to validate the device's accuracy or effectiveness.

    Therefore, I cannot provide the requested information from the given input. To answer your questions, I would need access to the actual 510(k) submission document or a summary thereof, which typically includes the performance data and study details.

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