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

    BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK)

    K Number: K992196 · Decision Sep 10, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    10
    Applicant Total
    5
    Review Days
    72

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    Basic Information

    Device Name
    BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK)
    K Number
    K992196
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5870
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hemocleanse, Inc.
    Date Received
    June 30, 1999
    Decision Date
    September 10, 1999
    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
    K984546 BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK
    K953751 BIOLOGIC-DT SYSTEM
    K923046 BIOLOGIC DT-1000 MACHINE