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

    DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020

    K Number: K911125 · Decision Aug 15, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    84
    Applicant Total
    16
    Review Days
    155

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    Basic Information

    Device Name
    DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020
    K Number
    K911125
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Diagnostic Ultrasound Corp.
    Date Received
    March 13, 1991
    Decision Date
    August 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

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    Other Clearances by Diagnostic Ultrasound Corp.

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    K963585 BLADDER MANAGER PCI 5000, BLADDERSCAN BVI 5000
    K955840 BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000
    K955942 BLADDERSCAN BVI 5000
    K920664 DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020, GI VERSION
    K915342 UD 2000 VIDEO OPTION
    K915436 BLADDERSCAN BVI 2500
    K911166 DIAGNOSTIC ULTRASOUND/URO-GYN UD 511
    Search all 16 clearances from Diagnostic Ultrasound Corp. →