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

    MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER

    K Number: K940426 · Decision Sep 20, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    5
    Review Days
    232

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    Basic Information

    Device Name
    MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER
    K Number
    K940426
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5400
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Hemotec, Inc.
    Date Received
    January 31, 1994
    Decision Date
    September 20, 1994
    Product Code
    GKN
    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
    GKN Timer, Clot, Automated

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