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

    VITAL COUGH

    K Number: K132988 · Decision Mar 28, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    24
    Applicant Total
    2
    Review Days
    185

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    Basic Information

    Device Name
    VITAL COUGH
    K Number
    K132988
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lung Assist, Inc.
    Date Received
    September 24, 2013
    Decision Date
    March 28, 2014
    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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    Other Clearances by Lung Assist, Inc.

    K Number Device Name
    K120277 VITAL COUGH