BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    COMFORT COUGH

    K Number: K113549 · Decision Feb 21, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    24
    Applicant Total
    1
    Review Days
    448

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    Basic Information

    Device Name
    COMFORT COUGH
    K Number
    K113549
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Seoil Pacific Corp.
    Date Received
    December 1, 2011
    Decision Date
    February 21, 2013
    Product Code
    NHJ
    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
    NHJ Device, Positive Pressure Breathing, Intermittent

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