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

    URO-PRO 2000

    K Number: K922476 · Decision Jul 20, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    84
    Applicant Total
    11
    Review Days
    420

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    Basic Information

    Device Name
    URO-PRO 2000
    K Number
    K922476
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Fiberoptic Sensor Technlogies, Inc.
    Date Received
    May 26, 1992
    Decision Date
    July 20, 1993
    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 Fiberoptic Sensor Technlogies, Inc.

    K Number Device Name
    K945753 FST FIBEROPTIC PRESSURE CONVERTER
    K950908 FST CATH-UD, CATHETER
    K945495 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION
    K930171 FST DUAL, DUAL PRESSURE URODYNAMICS MONITOR
    K922776 FST COUNCIL TIP FOLEY CATHETER
    K926088 FST CATH UD-DUAL DUAL PRESSURE CATHETER
    K913113 FST CATH-UD CATHETER, MODIFICATION
    K913721 FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM
    K905641 FST CATH-UD CATHETER
    K864000 FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00
    Search all 11 clearances from Fiberoptic Sensor Technlogies, Inc. →