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

    DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES

    K Number: K923529 · Decision Aug 29, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    56
    Applicant Total
    21
    Review Days
    774

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    Basic Information

    Device Name
    DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES
    K Number
    K923529
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Seratronics, Inc.
    Date Received
    July 16, 1992
    Decision Date
    August 29, 1994
    Product Code
    LIF
    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
    LIF Dialyzer Reprocessing System

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    Other Clearances by Seratronics, Inc.

    K Number Device Name
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    K874573 FRESENIUS PURISTERIL 340 (TM)
    K874872 FRESENIUS HEMOFLOW F3, F4, F5, F7
    K870725 FRESENIUS HEMOFLOW F6 AND F8
    K870724 FRESENIUS HEMOFLOW F60 AND F80
    K864587 FRESENIUS ULTRAFLUX AV400, AV600
    K864169 FRESENIUS HEMOFLOW F50 & F70
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