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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name audiometer
510(K) Number K121512
Device Name SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
Applicant
BIO-LOGIC SYSTEMS CORP.
one biologic plaza
mundelein,  IL  60060
Contact don williams
Regulation Number874.1050
Classification Product Code
EWO  
Date Received05/21/2012
Decision Date 07/26/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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