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

    ELVI 810 CLOTSCANNER

    K Number: K791587 · Decision Sep 17, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    13
    Applicant Total
    66
    Review Days
    31

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    Basic Information

    Device Name
    ELVI 810 CLOTSCANNER
    K Number
    K791587
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5400
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Volu Sol Medical Industries
    Date Received
    August 17, 1979
    Decision Date
    September 17, 1979
    Product Code
    KQG
    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
    KQG Instrument, Coagulation

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