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510(k) Data Aggregation

    K Number
    K101629
    Device Name
    FIL 1520
    Manufacturer
    GLENN MEDICAL SYSTEMS, INC.
    Date Cleared
    2010-07-09

    (29 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Glenn Medical oxygen concentrator filter model FIL 1520 is intended to help remove air-borne contaminants, including air borne bacteria and other particulate debris from the air stream of an oxygen concentrator. The device is only used for Invacare Oxygen Concentrator.

    Device Description

    Glenn Oxygen Concentrator Filter, model FIL 1520

    AI/ML Overview

    This FDA letter is a 510(k) premarket notification for a medical device called the "Glenn Oxygen Concentrator Filter, model FIL 1520." It acknowledges the manufacturer's intent to market the device and determines it is substantially equivalent to legally marketed predicate devices.

    The document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert reviews as typically outlined for AI/ML device evaluations. This letter is a regulatory approval document based on substantial equivalence to existing devices, not a performance study report.

    Therefore, I cannot provide the requested information. The document focuses solely on the regulatory approval process and the device's intended use, not on detailed performance validation.

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