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

    AQUA-GEL

    K Number: K781032 · Decision Dec 15, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    179

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    Basic Information

    Device Name
    AQUA-GEL
    K Number
    K781032
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Murray, Salk, Inc.
    Date Received
    June 19, 1978
    Decision Date
    December 15, 1978
    Product Code
    EXQ
    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
    EXQ Cystometer, Electrical Recording

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