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

    F.M. WEIST,KG (URODYNAMIC SYSTEMS)

    K Number: K860571 · Decision Mar 18, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    84
    Applicant Total
    12
    Review Days
    32

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    Basic Information

    Device Name
    F.M. WEIST,KG (URODYNAMIC SYSTEMS)
    K Number
    K860571
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    F.M. Wiest USA, Inc.
    Date Received
    February 14, 1986
    Decision Date
    March 18, 1986
    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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    K910883 LAPAROFLATOR ELECTRONIC 3509
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