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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 K143395
Device Name Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit
Applicant
Otodynamics, Ltd.
30-38 Beaconsfield Rd.
Hatfield, Herts,  GB AL10 8BB
Applicant Contact Julian Rutherford
Correspondent
Quintiles Consulting
1801 Rockville Pike Suite 300
Rockville,  MD  20852
Correspondent Contact Christopher M Sloan
Regulation Number874.1050
Classification Product Code
EWO  
Date Received11/26/2014
Decision Date 02/23/2015
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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