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

    OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID

    K Number: K897023 · Decision Mar 16, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    23
    Applicant Total
    8
    Review Days
    87

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    Basic Information

    Device Name
    OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID
    K Number
    K897023
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Audina Hearing Instrument
    Date Received
    December 19, 1989
    Decision Date
    March 16, 1990
    Product Code
    LRB
    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
    LRB Face Plate Hearing Aid

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    K930271 BEHIND-THE-EAR HEARING AID
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