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

    WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00

    K Number: K991437 · Decision Aug 30, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    15
    Review Days
    126

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    Basic Information

    Device Name
    WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00
    K Number
    K991437
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Wells Johnson Co.
    Date Received
    April 26, 1999
    Decision Date
    August 30, 1999
    Product Code
    FRN
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FRN Pump, Infusion

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