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

    BIOLOGIC-DT SYSTEM

    K Number: K953751 · Decision Feb 15, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    10
    Applicant Total
    5
    Review Days
    189

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    Basic Information

    Device Name
    BIOLOGIC-DT SYSTEM
    K Number
    K953751
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5870
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hemocleanse, Inc.
    Date Received
    August 10, 1995
    Decision Date
    February 15, 1996
    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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    Other Clearances by Hemocleanse, Inc.

    K Number Device Name
    K993330 THERMOCHEM-HT SYSTEM
    K992196 BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK)
    K984546 BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK
    K923046 BIOLOGIC DT-1000 MACHINE