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

    LUNG DIFFUSION GAS

    K Number: K873586 · Decision Feb 12, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    31
    Applicant Total
    2
    Review Days
    161

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    Basic Information

    Device Name
    LUNG DIFFUSION GAS
    K Number
    K873586
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.6400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    National Welders
    Date Received
    September 4, 1987
    Decision Date
    February 12, 1988
    Product Code
    BXK
    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
    BXK Gas, Calibration (Specified Concentration)

    Similar 510(k) Clearances

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    Other Clearances by National Welders

    K Number Device Name
    K873587 BLOOD ANALYSIS GAS