BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Hemo Control (optional Add Pack Hemo Control DM)

    K Number: K200909 · Decision Jun 12, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    38
    Applicant Total
    4
    Review Days
    67

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    Basic Information

    Device Name
    Hemo Control (optional Add Pack Hemo Control DM)
    K Number
    K200909
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    864.5620
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ekf-Diagnostic GmbH
    Date Received
    April 6, 2020
    Decision Date
    June 12, 2020
    Product Code
    GKR
    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
    GKR System, Hemoglobin, Automated

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