BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇭🇰 Hong Kong

    MIL CM-II COAGULATION MACHINE

    K Number: K913320 · Decision Jun 16, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    24
    Review Days
    327

    Basic Information

    Device Name
    MIL CM-II COAGULATION MACHINE
    K Number
    K913320
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5400
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    MEDICAL INNOVATIONS CORP.
    Date Received
    July 25, 1991
    Decision Date
    June 16, 1992
    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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