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

    UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK

    K Number: K844503 · Decision Jan 2, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    84
    Applicant Total
    13
    Review Days
    43

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    Basic Information

    Device Name
    UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK
    K Number
    K844503
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Epcom Medical Systems, Inc.
    Date Received
    November 20, 1984
    Decision Date
    January 2, 1985
    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 Epcom Medical Systems, Inc.

    K Number Device Name
    K910518 GLOVE-N-GEL AMNIOTOMY KIT
    K905812 INTRAUTERINE CATHETER SET
    K881414 CERVICATH
    K871079 FETALFLEX FETAL ELECTRODE
    K844338 1URO-LOG HOME DIAGNOSTIC PACK
    K841805 OBSTETRICAL DOPPLER
    K831115 EPCOM EMS-320 REMOTE MONITORSCOPE
    K831113 EPCOM EMS-310 INTRAPARTUM MONITOR
    K831114 EPCOM EMS-330 FREEDOM I TELEDOP OBSTET
    K831112 EPCOM VCU-1 VACUUM SYSTEM & CURETTE
    Search all 13 clearances from Epcom Medical Systems, Inc. →