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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tympanometer
510(k) Number K150163
Device Name Otowave 202 Portable Tympanometer
Applicant
Amplivox, Ltd.
6 Oasis Park
Eynsham,  GB OX29 4tp
Applicant Contact Chris Roerig
Correspondent
Kamm & Associates
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number874.1090
Classification Product Code
NAS  
Date Received01/26/2015
Decision Date 04/23/2015
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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