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

    Precision Flow® HVNI

    K Number: DEN170001 · Decision Apr 10, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    2
    Applicant Total
    13
    Review Days
    462

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    Basic Information

    Device Name
    Precision Flow® HVNI
    K Number
    DEN170001
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    868.5454
    Medical Specialty
    Anesthesiology
    Decision
    Unknown
    Applicant
    Vapotherm, Inc.
    Date Received
    January 3, 2017
    Decision Date
    April 10, 2018
    Product Code
    QAV
    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
    QAV High Flow/High Velocity Humidified Oxygen Delivery Device

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