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

    PLATELETWORKS, MODELS PW-A, PW-C

    K Number: K023761 · Decision Feb 14, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    37
    Applicant Total
    280
    Review Days
    98

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    Basic Information

    Device Name
    PLATELETWORKS, MODELS PW-A, PW-C
    K Number
    K023761
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5700
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Helena Laboratories
    Date Received
    November 8, 2002
    Decision Date
    February 14, 2003
    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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