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

    BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK

    K Number: K984546 · Decision Aug 13, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    10
    Applicant Total
    5
    Review Days
    234

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    Basic Information

    Device Name
    BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK
    K Number
    K984546
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5870
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hemocleanse, Inc.
    Date Received
    December 22, 1998
    Decision Date
    August 13, 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 510(k) clearances with the same product code (FLD), ordered by most recent decision date.

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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)
    K953751 BIOLOGIC-DT SYSTEM
    K923046 BIOLOGIC DT-1000 MACHINE