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

    URODYNAMIC MEASURING SYSTEM

    K Number: K910371 · Decision May 15, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    84
    Applicant Total
    7
    Review Days
    106

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    URODYNAMIC MEASURING SYSTEM
    K Number
    K910371
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Browne Medical Systems, Inc.
    Date Received
    January 29, 1991
    Decision Date
    May 15, 1991
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FAP), ordered by most recent decision date.

    SIGNAL GEAR URETHRAL CATHETER ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    URODYNAMIC ANALYSIS MODULE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SCHUSTER DISPOSABLE BALLOON PROBE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    UROLAB SPECTRUM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Browne Medical Systems, Inc.

    K Number Device Name
    K920992 PROFILE PLUS URODYNAMICS MEASURING SYST, MODIFIED
    K920991 IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION
    K921047 MODEL 8100 URODYNAMICS MEASURING SYSTEM
    K910444 BROWNE MEDICAL SYSTEMS IMAGEPRO
    K910285 BROWNE MEDICAL SYST.INC STAND-ALONE WATER PUMP
    K910217 MINIPRO 8100 URODYNAMIC MEASUREING SYSTEM