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

    AF-220 HEMODIALYZER

    K Number: K992573 · Decision Jan 18, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    343
    Applicant Total
    7
    Review Days
    169

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    Basic Information

    Device Name
    AF-220 HEMODIALYZER
    K Number
    K992573
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5860
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Althin Medical AB
    Date Received
    August 2, 1999
    Decision Date
    January 18, 2000
    Product Code
    KDI
    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
    KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

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    Other Clearances by Althin Medical AB

    K Number Device Name
    K992564 AF-180 HEMODIALYZER
    K992563 A-22 HEMODIALYZER
    K992566 AF-150 HEMODIALYZER
    K992594 A-15 HEMODIALYZER
    K992565 A-18 HEMODIALYZER
    K990010 ALTHIN MEDICAL AB ALTRACART II