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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 K900096
Device Name INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA)
Applicant
ARTIFICAL HEARING SYSTEMS CORP.
1125 N.E. 125 STREET, SUITE
206
NORTH MIAMI,  FL  33161
Applicant Contact EDWARD MISKIEL
Correspondent
ARTIFICAL HEARING SYSTEMS CORP.
1125 N.E. 125 STREET, SUITE
206
NORTH MIAMI,  FL  33161
Correspondent Contact EDWARD MISKIEL
Regulation Number874.1050
Classification Product Code
EWO  
Date Received01/08/1990
Decision Date 05/31/1990
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
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