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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name reduced- montage standard electroencephalograph
510(k) Number K092477
Device Name NEUROSENSE MONITORING SYSTEM, MODEL NS-701
Applicant
NEUROWAVE SYSTEMS, INC.
2490 LEE BLVD.
SUITE 300
CLEVELAND HEIGHTS,  OH  44118
Applicant Contact TRACIE CAPOZZIO
Correspondent
NEUROWAVE SYSTEMS, INC.
2490 LEE BLVD.
SUITE 300
CLEVELAND HEIGHTS,  OH  44118
Correspondent Contact TRACIE CAPOZZIO
Regulation Number882.1400
Classification Product Code
OMC  
Date Received08/12/2009
Decision Date 10/29/2010
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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