LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K994074
    Device Name
    TRI-BALL
    Manufacturer
    LEVENTON, S.A.
    Date Cleared
    2000-06-08

    (189 days)

    Product Code
    BWF
    Regulation Number
    868.5690
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TRI-BALL is an incentive spirometer, in other words, a respiratory execiser, The THI-BALL Is an Incentive spiratory flow rate and that provides an incentive to the patient to improve his or her ventilation.

    Device Description

    The TRI-BALL is an incentive spirometer, in other words, a respiratory execiser, The THI-BALL Is an Incentive spiratory flow rate and that provides an incentive to the patient to improve his or her ventilation.

    AI/ML Overview

    This is a 510(k) premarket notification letter from the FDA. It does not contain information about acceptance criteria or a study proving a device meets them. It primarily states that the TRI-BALL device is substantially equivalent to a legally marketed predicate device.

    Therefore, I cannot provide the requested information based on the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1