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

    AIR CONDUCTION IN-THE-EAR HEARING AID UA/115/SCR

    K Number: K872645 · Decision Dec 8, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    23
    Applicant Total
    71
    Review Days
    155

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    Basic Information

    Device Name
    AIR CONDUCTION IN-THE-EAR HEARING AID UA/115/SCR
    K Number
    K872645
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Richards Medical Co., Inc.
    Date Received
    July 6, 1987
    Decision Date
    December 8, 1987
    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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