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

    MEDLEY PCA MODULE, MODEL 8120

    K Number: K043299 · Decision Dec 10, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    30
    Applicant Total
    16
    Review Days
    10

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    Basic Information

    Device Name
    MEDLEY PCA MODULE, MODEL 8120
    K Number
    K043299
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alaris Medical Systems, Inc.
    Date Received
    November 30, 2004
    Decision Date
    December 10, 2004
    Product Code
    MEA
    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
    MEA Pump, Infusion, Pca

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    Other Clearances by Alaris Medical Systems, Inc.

    K Number Device Name
    K041241 MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600
    K031741 MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300
    K032233 MEDLEY PCA MODULE, MODEL 8120
    K032147 SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES
    K030459 MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS)
    K023264 MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110
    K022677 MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE
    K022209 ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS
    K013087 SINGLE DOSE DISPENSING PIN, MODEL 2201
    K012383 GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C
    Search all 16 clearances from Alaris Medical Systems, Inc. →