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

    CUSTOM IN-THE-EAR HEARING AID SERIES MCA20

    K Number: K873468 · Decision Sep 29, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    1366
    Applicant Total
    58
    Review Days
    32

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    Basic Information

    Device Name
    CUSTOM IN-THE-EAR HEARING AID SERIES MCA20
    K Number
    K873468
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Maico Hearing Instruments, Inc.
    Date Received
    August 28, 1987
    Decision Date
    September 29, 1987
    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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