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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 K023859
Device Name SMARTTROAE
Applicant
INTELLIGENT HEARING SYSTEMS
7356 S.W. 48 ST.
MIAMI,  FL  33155
Applicant Contact EDWARD MISKIEL
Correspondent
INTELLIGENT HEARING SYSTEMS
7356 S.W. 48 ST.
MIAMI,  FL  33155
Correspondent Contact EDWARD MISKIEL
Regulation Number874.1050
Classification Product Code
EWO  
Date Received11/20/2002
Decision Date 01/08/2003
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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