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510(k) Data Aggregation

    K Number
    K960884
    Device Name
    TELE TRENS TM 10
    Manufacturer
    LIFE SENSING INSTRUMENT COMPANY, INC.
    Date Cleared
    1997-09-12

    (557 days)

    Product Code
    DSI
    Regulation Number
    870.1025
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    K120052
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TeleTrens is intended for use in the non-invasive monitoring of ECG, blood pressure, pulse rate, pulse oximetry, temperature and respiration in the hospital/clinic environment.

    The TeleTrens is intended to be used in accordance with accepted hospital and clinical protocols and instructions contained in this operators manual. Use of the TeleTrens for applications not specified in this manual may result in inaccurate patient information. Use of the TeleTrens with other than recommended or supplied accessories or parts may result in inaccurate patient information or damage to the monitor.

    Federal law restricts this device to sale by or on the order of a physician.

    Device Description

    Not Found

    AI/ML Overview

    The provided text does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. The document is an FDA letter granting 510(k) clearance for the TeleTrens Model Number TM10, outlining its indications for use and regulatory status. It does not include a study summary or performance data.

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