BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    A-18 HEMODIALYZER

    K Number: K992565 · Decision Sep 23, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    130
    Applicant Total
    7
    Review Days
    52

    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
    A-18 HEMODIALYZER
    K Number
    K992565
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Althin Medical AB
    Date Received
    August 2, 1999
    Decision Date
    September 23, 1999
    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 Althin Medical AB

    K Number Device Name
    K992564 AF-180 HEMODIALYZER
    K992563 A-22 HEMODIALYZER
    K992566 AF-150 HEMODIALYZER
    K992573 AF-220 HEMODIALYZER
    K992594 A-15 HEMODIALYZER
    K990010 ALTHIN MEDICAL AB ALTRACART II