BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500

    K Number: K884046 · Decision Feb 13, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    45
    Applicant Total
    2
    Review Days
    140

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    Basic Information

    Device Name
    AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500
    K Number
    K884046
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3310
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Etymonic Design, Inc.
    Date Received
    September 26, 1988
    Decision Date
    February 13, 1989
    Product Code
    ETW
    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
    ETW Calibrator, Hearing Aid / Earphone And Analysis Systems

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    Other Clearances by Etymonic Design, Inc.

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