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

    MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300

    K Number: K031741 · Decision Feb 9, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    304
    Applicant Total
    16
    Review Days
    250

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    Basic Information

    Device Name
    MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300
    K Number
    K031741
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alaris Medical Systems, Inc.
    Date Received
    June 4, 2003
    Decision Date
    February 9, 2004
    Product Code
    CCK
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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    Other Clearances by Alaris Medical Systems, Inc.

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    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
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