Search Results
Found 1 results
510(k) Data Aggregation
K Number
K982878Device Name
EARSCAN 3
Manufacturer
Date Cleared
1998-11-03
(81 days)
Product Code
Regulation Number
874.1050Why 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.
Ask a Question
Ask a specific question about this device
Page 1 of 1