BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MINNILERT AIR DETECTOR

    K Number: K904992 · Decision Feb 5, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    33
    Review Days
    90

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    Basic Information

    Device Name
    MINNILERT AIR DETECTOR
    K Number
    K904992
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Minntech Corp.
    Date Received
    November 7, 1990
    Decision Date
    February 5, 1991
    Product Code
    FJF
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FJF Detector, Air Bubble

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