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

    HEPCON HMS WITH BODY SURFACE AREA CALCULATION

    K Number: K911240 · Decision Jul 17, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    118

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    Basic Information

    Device Name
    HEPCON HMS WITH BODY SURFACE AREA CALCULATION
    K Number
    K911240
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5680
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Hemotech, Inc.
    Date Received
    March 21, 1991
    Decision Date
    July 17, 1991
    Product Code
    JOX
    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
    JOX Analyzer, Heparin, Automated

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