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

    Eustachi Ear Pressure Relief Device

    K Number: K203754 · Decision Feb 19, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    58

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    Basic Information

    Device Name
    Eustachi Ear Pressure Relief Device
    K Number
    K203754
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Exercore, LLC
    Date Received
    December 23, 2020
    Decision Date
    February 19, 2021
    Product Code
    MJV
    Advisory Committee
    Unknown
    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
    MJV Device, Inflation, Middle Ear

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