BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    OMNI

    K Number: K811158 · Decision May 27, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    7
    Review Days
    29

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    Basic Information

    Device Name
    OMNI
    K Number
    K811158
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Omni Hearing Systems
    Date Received
    April 28, 1981
    Decision Date
    May 27, 1981
    Product Code
    ESD
    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
    ESD Hearing Aid, Air-Conduction, Prescription

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    Other Clearances by Omni Hearing Systems

    K Number Device Name
    K843921 IN THE CANAL HEARING AID RC, REDICANAL
    K833333 IN THE EAR HEARING AID OMNI 100
    K833334 BEHIND THE EAR ASP-BB
    K833451 TEL-STAR NUWAY & GENERIC E ASP-BP
    K830459 BEHIND THE EAR HEARING AID OMNI #OS
    K823178 TEL-STAR NU-WAY & GENERIC E