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510(k) Data Aggregation

    K Number
    K032143
    Device Name
    LIQUID OXYGEN SYSTEM
    Manufacturer
    MICRO TECHNOLOGY SERVICES, INC.
    Date Cleared
    2004-03-30

    (260 days)

    Product Code
    BYJ
    Regulation Number
    868.5655
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LOX-Stat electronic contents gauge is intended for use with the Puritan Bennett companion 21/31/41 Liquid Oxygen Reservoirs to digitally display the liquid oxygen content remaining in the tank.

    Device Description

    LOX-Stat Liquid Oxygen Reservoir Content Gauge

    AI/ML Overview

    This is a letter for a 510(k) premarket notification for a medical device called "LOX-Stat Liquid Oxygen Reservoir Content Gauge". It indicates that the device has been found substantially equivalent to a legally marketed predicate device.

    The document does not contain the requested information regarding acceptance criteria, device performance results, study details (sample sizes, provenance, ground truth, experts, adjudication, MRMC, standalone), or training set information. It is a regulatory clearance letter, not a study report.

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