BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PFT GASES

    K Number: K781523 · Decision Dec 1, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    6
    Applicant Total
    2
    Review Days
    87

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    Basic Information

    Device Name
    PFT GASES
    K Number
    K781523
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.2350
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Gardner Cryogenics
    Date Received
    September 5, 1978
    Decision Date
    December 1, 1978
    Product Code
    BXY
    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
    BXY Flowmeter, Calibration, Gas

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