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

    DUODENOSCOPE, MOLEL TX-6

    K Number: K770754 · Decision Apr 28, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    8
    Applicant Total
    9
    Review Days
    3

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    Basic Information

    Device Name
    DUODENOSCOPE, MOLEL TX-6
    K Number
    K770754
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5700
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    American Cystocope Makers, Inc.
    Date Received
    April 25, 1977
    Decision Date
    April 28, 1977
    Product Code
    FOG
    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
    FOG Hood, Oxygen, Infant

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