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

    CUSTOM IN-THE-EAR

    K Number: K863975 · Decision Nov 7, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    10
    Review Days
    24

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    Basic Information

    Device Name
    CUSTOM IN-THE-EAR
    K Number
    K863975
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Gn Danavox, Inc.
    Date Received
    October 14, 1986
    Decision Date
    November 7, 1986
    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 Gn Danavox, Inc.

    K Number Device Name
    K971032 DANAVOX MODELS 163/162 BTE
    K971031 AUDALLION III HEARING SYSTEM
    K942331 DANAVOX MODEL CIC
    K924185 DFS GENIUS BTE
    K905692 143 SERIES BTE
    K905679 133 SERIES BTE
    K896996 CAS (COMPUTERIZED ANALYZER SYSTEM)
    K896995 DISCRETION, IN THE CANAL HEARING INSTRUMENT
    K891594 CERUMEN FILTER