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

    FRESENIUS HAEMODIALYSIS ;MACHINE A1008

    K Number: K844641 · Decision Feb 14, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    60
    Applicant Total
    21
    Review Days
    78

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    FRESENIUS HAEMODIALYSIS ;MACHINE A1008
    K Number
    K844641
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Seratronics, Inc.
    Date Received
    November 28, 1984
    Decision Date
    February 14, 1985
    Product Code
    FKQ
    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
    FKQ System, Dialysate Delivery, Central Multiple Patient

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FKQ), ordered by most recent decision date.

    DIACAP ULTRA DIALYSIS FLUID FILTER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TWO TANK DISSOLUTION MODULE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    KAWASUMI A.V. FISTULA SET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ACID FUCHSIN SOLUTIONS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ACTRIL FOR KIDNEY MACHINE DISINFECTANT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Seratronics, Inc.

    K Number Device Name
    K955299 DPS 4 DIALYZER PREPARATION SYSTEM
    K931336 DRS 4 DIALYZER REPROCESSING SYSTEM
    K944539 DRS 4 ND 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
    Search all 21 clearances from Seratronics, Inc. →