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

    PATI (Protector Against Tongue Injury)

    K Number: K221469 · Decision Feb 22, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    27
    Applicant Total
    1
    Review Days
    278

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    Basic Information

    Device Name
    PATI (Protector Against Tongue Injury)
    K Number
    K221469
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5070
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neurovice, LLC
    Date Received
    May 20, 2022
    Decision Date
    February 22, 2023
    Product Code
    JXL
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JXL Block, Bite

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