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

    522 INTELLIGENT PUMP

    K Number: K882159 · Decision Aug 24, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    13
    Review Days
    93

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    Basic Information

    Device Name
    522 INTELLIGENT PUMP
    K Number
    K882159
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Kendall Mcgaw Laboratories, Inc.
    Date Received
    May 23, 1988
    Decision Date
    August 24, 1988
    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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    Other Clearances by Kendall Mcgaw Laboratories, Inc.

    K Number Device Name
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    K904518 VOLUMETRIC INFUSION PUMP
    K903809 PROTECTED NEEDLE WITH OR WITHOUT IV SET
    K901065 INFUSION PUMP
    K900865 ADD-A-VIAL II BINARY CONNECTOR
    K896292 1.2 MICRON FILTER WITH IV SET
    K895109 SECONDARY IV SET WITH PROTECTED NEEDLE
    K874467 SET, ADMINISTRATION INTRAVASCULAR
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