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

    ALTHIN MEDICAL AB ALTRACART II

    K Number: K990010 · Decision Apr 15, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    122
    Applicant Total
    7
    Review Days
    101

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    Basic Information

    Device Name
    ALTHIN MEDICAL AB ALTRACART II
    K Number
    K990010
    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
    January 4, 1999
    Decision Date
    April 15, 1999
    Product Code
    KPO
    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
    KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

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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
    K992573 AF-220 HEMODIALYZER
    K992594 A-15 HEMODIALYZER
    K992565 A-18 HEMODIALYZER