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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, auditory, evoked response
510(k) Number K163326
Device Name SmartEP
Applicant
INTELLIGENT HEARING SYSTEMS
6860 SW 81ST st Street
MIAMI,  FL  33143
Applicant Contact Edward Miskiel
Correspondent
INTELLIGENT HEARING SYSTEMS
6860 SW 81ST st Street
MIAMI,  FL  33143
Correspondent Contact Edward Miskiel
Regulation Number882.1900
Classification Product Code
GWJ  
Subsequent Product Codes
ETN   GWE   GWF  
Date Received11/28/2016
Decision Date 09/29/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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