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

    cNEP Airway

    K Number: DEN140024 · Decision Dec 23, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    492

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    Basic Information

    Device Name
    cNEP Airway
    K Number
    DEN140024
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    868.5105
    Medical Specialty
    Anesthesiology
    Decision
    Unknown
    Applicant
    Sommetrics
    Date Received
    August 18, 2014
    Decision Date
    December 23, 2015
    Product Code
    PMB
    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
    PMB External Airway