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

    SERIM HISENSE ULTRA 0.1, PART NUMBER 5167

    K Number: K080712 · Decision May 6, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    12
    Applicant Total
    27
    Review Days
    54

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    Basic Information

    Device Name
    SERIM HISENSE ULTRA 0.1, PART NUMBER 5167
    K Number
    K080712
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5665
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Serim Research Corp.
    Date Received
    March 13, 2008
    Decision Date
    May 6, 2008
    Product Code
    MSY
    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
    MSY Strip, Test, Reagent, Residuals For Dialysate, Disinfectant

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