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510(k) Data Aggregation

    K Number
    K982878
    Device Name
    EARSCAN 3
    Date Cleared
    1998-11-03

    (81 days)

    Product Code
    Regulation Number
    874.1050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO AUDIOMETRICS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Earscan 3 is a peripheral used with a computer that creates an air conduction, bone conduction and speech audiometer, as defined by the standards shown in the labeling of the About Screen and the Splash Screen of the Earscan 3 software.
    Device Description
    The Earscan 3 is similar to and predicated upon the Micro Audiometrics Corp. Earscan and Earscan II, and Decibel Instruments, Inc. ProDigit 2000. Earscan 3 is a computer peripheral whose purpose is to test the condition of the auditory pathway through manual and automatic air conduction audiometry, bone conduction audiometry and speech audiometry. Earscan 3 is a lower level of concern device and is intended to be used by trained personnel in the industrial, school and medical environment.
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