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

    DISA WATER CYSTOMETER

    K Number: K820144 · Decision Mar 23, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    84
    Applicant Total
    2
    Review Days
    63

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    Basic Information

    Device Name
    DISA WATER CYSTOMETER
    K Number
    K820144
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Disa Electronics
    Date Received
    January 19, 1982
    Decision Date
    March 23, 1982
    Product Code
    FAP
    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
    FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

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    Other Clearances by Disa Electronics

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