BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER

    K Number: K905704 · Decision Apr 30, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    69
    Applicant Total
    58
    Review Days
    130

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    Basic Information

    Device Name
    MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER
    K Number
    K905704
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1090
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Maico Hearing Instruments, Inc.
    Date Received
    December 21, 1990
    Decision Date
    April 30, 1991
    Product Code
    ETY
    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
    ETY Tester, Auditory Impedance

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