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

    ALTR NOVA 110 HEMODIALYZER

    K Number: K952983 · Decision Oct 5, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    336
    Applicant Total
    27
    Review Days
    99

    Basic Information

    Device Name
    ALTR NOVA 110 HEMODIALYZER
    K Number
    K952983
    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 AN AFFILIATE OF BAXTER INTL
    Date Received
    June 28, 1995
    Decision Date
    October 5, 1995
    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 AN AFFILIATE OF BAXTER INTL

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    K964922 DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEM
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