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

    BLOOD ANALYSIS GAS

    K Number: K873587 · Decision Oct 30, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    31
    Applicant Total
    2
    Review Days
    56

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    BLOOD ANALYSIS GAS
    K Number
    K873587
    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
    October 30, 1987
    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

    Other 510(k) clearances with the same product code (BXK), ordered by most recent decision date.

    BLOOD GAS MIXTURES

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    LUNG DIFFUSION MIXTURES

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    LUNG DIFFUSION MIXTURE

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    MEDICAL MIXTURE-LUNG DIFFUSION GAS MIXTURES

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    MED-TECH LUNG DIFFUSION MIXTURE

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    MEDICAL MIXTURE-CLINICAL BLOOD GAS MIXTURES

    FDA 510(k)
    FDA Class 1 ·Anesthesiology
    View all

    Other Clearances by National Welders

    K Number Device Name
    K873586 LUNG DIFFUSION GAS