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

    IN THE EAR HEARING AID OMNI 100

    K Number: K833333 · Decision Dec 8, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    1366
    Applicant Total
    7
    Review Days
    72

    Basic Information

    Device Name
    IN THE EAR HEARING AID OMNI 100
    K Number
    K833333
    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
    September 27, 1983
    Decision Date
    December 8, 1983
    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

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    K830459 BEHIND THE EAR HEARING AID OMNI #OS
    K823178 TEL-STAR NU-WAY & GENERIC E
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