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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 K112247
Device Name A BAER WITH ABAER I/O FUNCTION
Applicant
NATUS MEDICAL INCORPORATED
388 MARKET STREET
SUITE 1460
SAN FRANCISCO,  CA  94111
Applicant Contact CHARLES L MORIN
Correspondent
NATUS MEDICAL INCORPORATED
388 MARKET STREET
SUITE 1460
SAN FRANCISCO,  CA  94111
Correspondent Contact CHARLES L MORIN
Regulation Number874.1050
Classification Product Code
EWO  
Subsequent Product Code
GWJ  
Date Received08/04/2011
Decision Date 04/02/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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