BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    ROTEM DELTA THROMBOELASTOMETRY SYSTEM

    K Number: K083842 · Decision Mar 23, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    180
    Applicant Total
    1
    Review Days
    454

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    Basic Information

    Device Name
    ROTEM DELTA THROMBOELASTOMETRY SYSTEM
    K Number
    K083842
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5425
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pentapharm GmbH
    Date Received
    December 24, 2008
    Decision Date
    March 23, 2010
    Product Code
    JPA
    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
    JPA System, Multipurpose For In Vitro Coagulation Studies

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