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

    PulmoScan

    K Number: K191876 · Decision Mar 18, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    247

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    Basic Information

    Device Name
    PulmoScan
    K Number
    K191876
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1840
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cognita Labs, LLC
    Date Received
    July 15, 2019
    Decision Date
    March 18, 2020
    Product Code
    PNV
    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
    PNV Impedance Measuring Device Utilizing Oscillation Techniques

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