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

    ISONEPHROS-PEDIATRIC, STANDARD, OPTIMUM

    K Number: K801451 · Decision Sep 26, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    35
    Applicant Total
    21
    Review Days
    95

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    Basic Information

    Device Name
    ISONEPHROS-PEDIATRIC, STANDARD, OPTIMUM
    K Number
    K801451
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Medical, Inc.
    Date Received
    June 23, 1980
    Decision Date
    September 26, 1980
    Product Code
    FJG
    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
    FJG Dialyzer, Parallel Flow

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