BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇬🇧 United Kingdom

    Phagenyx System

    K Number: DEN220025 · Decision Sep 16, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    150

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    Basic Information

    Device Name
    Phagenyx System
    K Number
    DEN220025
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    874.5950
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Unknown
    Applicant
    Phagenesis Limited
    Date Received
    April 19, 2022
    Decision Date
    September 16, 2022
    Product Code
    QQG
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QQG Oropharyngeal Electrical Stimulator