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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOIKE MEDICAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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.
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