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

    DIALYSIS MIXING & HOLDING TANK

    K Number: K961416 · Decision Aug 21, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    17
    Applicant Total
    1
    Review Days
    131

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    Basic Information

    Device Name
    DIALYSIS MIXING & HOLDING TANK
    K Number
    K961416
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dial Medical Supply
    Date Received
    April 12, 1996
    Decision Date
    August 21, 1996
    Product Code
    FIN
    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
    FIN Tank, Holding, Dialysis

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