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

    HEMOPERFUSION SYSTEM TP-400

    K Number: K840532 · Decision May 30, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    10
    Applicant Total
    69
    Review Days
    119

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    Basic Information

    Device Name
    HEMOPERFUSION SYSTEM TP-400
    K Number
    K840532
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5870
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Extracorporeal Medical Specialities, Inc.
    Date Received
    February 1, 1984
    Decision Date
    May 30, 1984
    Product Code
    FLD
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FLD Apparatus, Hemoperfusion, Sorbent

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