BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇿 New Zealand

    The AVEOtsd (Tongue Stabilizing Device) Mouthpiece

    K Number: K231663 · Decision Sep 18, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    106
    Same Product Code
    194
    Applicant Total
    1
    Review Days
    103

    Basic Information

    Device Name
    The AVEOtsd (Tongue Stabilizing Device) Mouthpiece
    K Number
    K231663
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5570
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Innovative Health Technologies (NZ), Ltd
    Date Received
    June 7, 2023
    Decision Date
    September 18, 2023
    Product Code
    LRK
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LRK Device, Anti-Snoring

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