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510(k) Data Aggregation

    K Number
    K981726
    Device Name
    PERCUSSIVETECH HF, MODEL 2001
    Manufacturer
    VORTRAN MEDICAL TECHNOLOGY 1, INC.
    Date Cleared
    1998-09-17

    (125 days)

    Product Code
    NHJ
    Regulation Number
    868.5905
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For use in the removal of mucus from the lungs of patients with retained endobronchial secretions.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the PercussiveTech HFTM device. It indicates that the device has been found substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. The document is primarily a regulatory approval notice and does not delve into the technical details of the device's validation studies.

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