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

    AIO Breathe

    K Number: K233754 · Decision Feb 23, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    26
    Applicant Total
    2
    Review Days
    93

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    AIO Breathe
    K Number
    K233754
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    872.5570
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aiomega, LLC
    Date Received
    November 22, 2023
    Decision Date
    February 23, 2024
    Product Code
    LQZ
    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
    LQZ Device, Jaw Repositioning

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LQZ), ordered by most recent decision date.

    RADx Intraoral Appliance for Snoring and Sleep Apnea

    FDA 510(k)
    FDA Class 2 ·Dental

    The Slide

    FDA 510(k)
    FDA Class 2 ·Dental

    Slow Wave DS8

    FDA 510(k)
    FDA Class 2 ·Dental

    The NightBlocks Appliance

    FDA 510(k)
    FDA Class 2 ·Dental

    SML-OSA2 Appliances

    FDA 510(k)
    FDA Class 2 ·Dental

    ATG/SM-OSA APPLIANCES

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    Other Clearances by Aiomega, LLC

    K Number Device Name
    K252525 AIO Breathe