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

    DRS 4 ND DIALYZER REPROCESSING SYSTEM

    K Number: K944539 · Decision Nov 29, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    56
    Applicant Total
    21
    Review Days
    440

    Basic Information

    Device Name
    DRS 4 ND DIALYZER REPROCESSING SYSTEM
    K Number
    K944539
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SERATRONICS, INC.
    Date Received
    September 15, 1994
    Decision Date
    November 29, 1995
    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
    K955299 DPS 4 DIALYZER PREPARATION SYSTEM
    K931336 DRS 4 DIALYZER REPROCESSING SYSTEM
    K923529 DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES
    K914580 DRS-4 DIALYZER REPROCESSING SYSTEM
    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
    Search all 21 clearances from SERATRONICS, INC. →