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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 K962995
Device Name ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC
Applicant
Otodynamics, Ltd.
36 Beaconsfield Rd.,
Hatfield Herts Al10 8bb,  GB AL10 8BB
Correspondent
Otodynamics, Ltd.
36 Beaconsfield Rd.,
Hatfield Herts Al10 8bb,  GB AL10 8BB
Regulation Number874.1050
Classification Product Code
EWO  
Date Received08/01/1996
Decision Date 01/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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