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

    BABYFLEX PATIENT CIRCUIT

    K Number: K874559 · Decision Dec 21, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    87
    Applicant Total
    1
    Review Days
    47

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    Basic Information

    Device Name
    BABYFLEX PATIENT CIRCUIT
    K Number
    K874559
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5975
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Airoflex Medical, Inc.
    Date Received
    November 4, 1987
    Decision Date
    December 21, 1987
    Product Code
    BZO
    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
    BZO Set, Tubing And Support, Ventilator (W Harness)

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