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

    CATHETER, URETHRAL PRESSURE, UPE-10 & 12

    K Number: K770579 · Decision May 23, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    84
    Applicant Total
    19
    Review Days
    56

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    Basic Information

    Device Name
    CATHETER, URETHRAL PRESSURE, UPE-10 & 12
    K Number
    K770579
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Life-Tech Instruments, Inc.
    Date Received
    March 28, 1977
    Decision Date
    May 23, 1977
    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 Life-Tech Instruments, Inc.

    K Number Device Name
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    K812178 LIFE-TECH #'S 1106/1156 UROLABS
    K800112 AMBLYOPIA TRAINER
    K790663 MODEL 1750 STANDING URINAL
    K790664 MODEL 1309 AUDIO MONITOR
    K781476 MULAR GOLD LEAF ELECTRODE MODEL 7501
    K781461 MODEL 7320 VISUAL STIMULATOR
    K781475 ELECTRODE IMPEDANCE TESTER-MODEL 500
    Search all 19 clearances from Life-Tech Instruments, Inc. →