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

    CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY

    K Number: K140893 · Decision Jan 3, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    37
    Applicant Total
    2
    Review Days
    270

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    Basic Information

    Device Name
    CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY
    K Number
    K140893
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5700
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Coramed Technologies, LLC
    Date Received
    April 8, 2014
    Decision Date
    January 3, 2015
    Product Code
    JOZ
    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
    JOZ System, Automated Platelet Aggregation

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    Other Clearances by Coramed Technologies, LLC

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