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

    CUSTOM IN-THE-EAR AND CANAL HEARING AID

    K Number: K862754 · Decision Aug 1, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    1
    Review Days
    10

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    Basic Information

    Device Name
    CUSTOM IN-THE-EAR AND CANAL HEARING AID
    K Number
    K862754
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Cochlear Laboratories, Ltd.
    Date Received
    July 22, 1986
    Decision Date
    August 1, 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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