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

    Westmed Gas Sampling Cannula with O2 delivery

    K Number: K162343 · Decision Dec 14, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    304
    Applicant Total
    8
    Review Days
    114

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    Basic Information

    Device Name
    Westmed Gas Sampling Cannula with O2 delivery
    K Number
    K162343
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1400
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Westmed, Inc.
    Date Received
    August 22, 2016
    Decision Date
    December 14, 2016
    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 Westmed, Inc.

    K Number Device Name
    K143148 Disposable Pressure Manometer (DPM)
    K133057 VIBRALUNG ACOUSTICAL PERCUSSOR
    K121382 WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)]
    K081905 ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP
    K072220 PEDI CO2 EASY
    K070128 CO2 EASY
    K953464 WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK