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

    TUBING, AEROSAL, DISPOSABLE

    K Number: K770354 · Decision Mar 16, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    87
    Applicant Total
    7
    Review Days
    22

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    Basic Information

    Device Name
    TUBING, AEROSAL, DISPOSABLE
    K Number
    K770354
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5975
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Inhal-O-Tech Medical Plastic
    Date Received
    February 22, 1977
    Decision Date
    March 16, 1977
    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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