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

    SIMPLICITY PLUS

    K Number: K831761 · Decision Aug 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    51
    Review Days
    72

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    Basic Information

    Device Name
    SIMPLICITY PLUS
    K Number
    K831761
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Critikon Company, LLC
    Date Received
    June 1, 1983
    Decision Date
    August 12, 1983
    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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