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

    INFUSION PUMP

    K Number: K831953 · Decision Jul 19, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    6
    Applicant Total
    6
    Review Days
    34

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    Basic Information

    Device Name
    INFUSION PUMP
    K Number
    K831953
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Cryosan, Inc.
    Date Received
    June 15, 1983
    Decision Date
    July 19, 1983
    Product Code
    FIR
    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
    FIR Pump, Blood, Extra-Luminal

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