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510(k) Data Aggregation

    K Number
    K964541
    Device Name
    SANPO I
    Manufacturer
    KOIKE MEDICAL CO.
    Date Cleared
    1997-09-26

    (329 days)

    Product Code
    NFB
    Regulation Number
    868.5905
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K833994
    Why did this record match?
    Reference Devices :

    K833994

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For use by adults in conjunction with portable oxygen supply units to conserve and regulate oxygen supply and consumption. SANPO is not intended for use by neo-natal or pediatric patients.

    Device Description

    oxygen conservation device, SANPO, which is intended for use in conjunction with oxygen supply systems to conserve and regulate oxygen supply and consumption.

    AI/ML Overview

    The provided text is a 510(k) summary for the SANPO oxygen conservation device. While it states the device's intended use and claims substantial equivalence to a predicate device, it does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

    The document is a regulatory approval letter and not a study report. It refers to the device's physical and technical characteristics being compared to the predicate, but it does not detail the specific characteristics compared, the criteria for "substantial similarity," or any empirical data from a study.

    Therefore, I cannot fulfill your request for the specific points because the necessary information is not present in the provided text.

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