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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 K111618
Device Name AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX 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  
Date Received06/10/2011
Decision Date 12/28/2011
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
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