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

    URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY

    K Number: K944972 · Decision Mar 8, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    15
    Applicant Total
    8
    Review Days
    148

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    Basic Information

    Device Name
    URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY
    K Number
    K944972
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1800
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Myo/Kinetic Systems, Inc.
    Date Received
    October 11, 1994
    Decision Date
    March 8, 1995
    Product Code
    EXY
    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
    EXY Uroflowmeter

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    K932399 THERAPEUTIC STIM 200 (TS-200)/200P (TS-200P)
    K914904 THERAPEUTIC STIMULATOR 2100 (TS-2100)