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

    DIRD INGANT O2 (BIO 2 HOOD)

    K Number: K895866 · Decision Oct 27, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    10
    Applicant Total
    35
    Review Days
    23

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    Basic Information

    Device Name
    DIRD INGANT O2 (BIO 2 HOOD)
    K Number
    K895866
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5700
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Bird Products Corp.
    Date Received
    October 4, 1989
    Decision Date
    October 27, 1989
    Product Code
    BYL
    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
    BYL Tent, Oxygen

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