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

    DIAGNOSTIC ULTRASOUND/URO-GYN UD 511

    K Number: K911166 · Decision Aug 15, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    209
    Applicant Total
    16
    Review Days
    153

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    Basic Information

    Device Name
    DIAGNOSTIC ULTRASOUND/URO-GYN UD 511
    K Number
    K911166
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Diagnostic Ultrasound Corp.
    Date Received
    March 15, 1991
    Decision Date
    August 15, 1991
    Product Code
    DXT
    Advisory Committee
    Cardiovascular
    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
    DXT Injector And Syringe, Angiographic

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    Other Clearances by Diagnostic Ultrasound Corp.

    K Number Device Name
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    K963585 BLADDER MANAGER PCI 5000, BLADDERSCAN BVI 5000
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    K955942 BLADDERSCAN BVI 5000
    K920664 DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020, GI VERSION
    K915342 UD 2000 VIDEO OPTION
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