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

    BLOOD GAS MIXTURE

    K Number: K932874 · Decision Jan 27, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    31
    Applicant Total
    2
    Review Days
    227

    Basic Information

    Device Name
    BLOOD GAS MIXTURE
    K Number
    K932874
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.6400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    TRI-GAS, INC.
    Date Received
    June 14, 1993
    Decision Date
    January 27, 1994
    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)

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    Other Clearances by TRI-GAS, INC.

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