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

    PLASMA THERAPY TUBESET-E100 SERIES

    K Number: K831747 · Decision Jun 30, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    76
    Applicant Total
    8
    Review Days
    29

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    Basic Information

    Device Name
    PLASMA THERAPY TUBESET-E100 SERIES
    K Number
    K831747
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Parker Hannifin Corp.
    Date Received
    June 1, 1983
    Decision Date
    June 30, 1983
    Product Code
    FJK
    Advisory Committee
    Gastroenterology, Urology
    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
    FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

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    K831402 PRESSURE MONITOR & CONTROL UNIT APC-02A
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