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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Non-Normalizing Quantitative Electroencephalograph Software
510(k) Number K142834
Device Name DiscoverEEG System, Model DE-401
Applicant
NeuroWave Systems Inc.
2490 Lee Blvd, Suite 300
Cleveland Heights,  OH  44118
Applicant Contact Tatjana Zikov
Correspondent
NeuroWave Systems Inc.
2490 Lee Blvd, Suite 300
Cleveland Heights,  OH  44118
Correspondent Contact Tatjana Zikov
Regulation Number882.1400
Classification Product Code
OLT  
Subsequent Product Code
OMC  
Date Received09/30/2014
Decision Date 06/23/2015
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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