BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    WSP CODE 4300 DIOMASTER DIAGNOSTIC

    K Number: K850696 · Decision May 17, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    84
    Applicant Total
    15
    Review Days
    85

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    Basic Information

    Device Name
    WSP CODE 4300 DIOMASTER DIAGNOSTIC
    K Number
    K850696
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Warne Surgical Products, Ltd.
    Date Received
    February 21, 1985
    Decision Date
    May 17, 1985
    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 Warne Surgical Products, Ltd.

    K Number Device Name
    K850694 WSP CODE 4310 STRESSCATH
    K850695 WSP CODE 4301 DIOMASTER THERAPEUTIC
    K850693 WSP CODE 4315 PADTEST
    K841511 HAEMATURIA CATHETERS
    K840687 KIDNEY TRANSPLANT CATHETER
    K841412 ROLLED NECK W/TAP
    K841409 BUSH NECK W/PLUG
    K841411 ROLLED NECK W/PLUG
    K841410 BUSH NECK W/TAP
    K840703 SECURE W/30MM DIAM, SHEATH & ADHESIVE
    Search all 15 clearances from Warne Surgical Products, Ltd. →