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

    GAMBRO GF-80-M, GF-80-H HEMODIALYZER

    K Number: K820304 · Decision Mar 2, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    130
    Applicant Total
    86
    Review Days
    26

    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
    GAMBRO GF-80-M, GF-80-H HEMODIALYZER
    K Number
    K820304
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Gambro, Inc.
    Date Received
    February 4, 1982
    Decision Date
    March 2, 1982
    Product Code
    FJI
    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
    FJI Dialyzer, Capillary, Hollow Fiber

    Similar 510(k) Clearances

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

    Hemoflow F3 and F4 Dialyzers

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

    NIPRO PUREFLUX-L HEMODIALYZER

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

    POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR

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

    DISPOSABLE STORAGE CAP

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

    ULTRACONCENTRATOR SYSTEM

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

    FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS

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

    Other Clearances by Gambro, Inc.

    K Number Device Name
    K083158 EXALIS, SOFTWARE VERSION 1.15
    K070643 PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35
    K032431 PRISMA M60/M100 SETS
    K896758 GAMBRO BICARBONATE MONITOR BCM 10-3
    K896757 GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS
    K902481 GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER
    K900918 GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER
    K892523 GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY
    K890112 ENGSTROM ELIZA + CO2 ANALYZER
    K890111 GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER
    Search all 86 clearances from Gambro, Inc. →