BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER

    K Number: K001409 · Decision Aug 2, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    68
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER
    K Number
    K001409
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5470
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hyperbaric Technologies, Inc.
    Date Received
    May 4, 2000
    Decision Date
    August 2, 2000
    Product Code
    CBF
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CBF Chamber, Hyperbaric

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    Other Clearances by Hyperbaric Technologies, Inc.

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