BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High

    K Number: K192842 · Decision Nov 15, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    14
    Applicant Total
    7
    Review Days
    43

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    Basic Information

    Device Name
    HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High
    K Number
    K192842
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.8625
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eurotrol B.V.
    Date Received
    October 3, 2019
    Decision Date
    November 15, 2019
    Product Code
    GGM
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GGM Control, Hemoglobin

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