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

    ULTepap Expiratory Positive Airway Pressure (EPAP) Device

    K Number: K191728 · Decision Feb 21, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    239

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    Basic Information

    Device Name
    ULTepap Expiratory Positive Airway Pressure (EPAP) Device
    K Number
    K191728
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5570
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bryggs Medical, LLC
    Date Received
    June 27, 2019
    Decision Date
    February 21, 2020
    Product Code
    OHP
    Advisory Committee
    Dental
    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
    OHP Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea

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