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

    TEG 6s Hemostasis System

    K Number: K160502 · Decision Apr 19, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    180
    Applicant Total
    7
    Review Days
    421

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    Basic Information

    Device Name
    TEG 6s Hemostasis System
    K Number
    K160502
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    864.5425
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Haemonetics Corporation
    Date Received
    February 23, 2016
    Decision Date
    April 19, 2017
    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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