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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 K110967
Device Name ENTERPRISE ELECTROPHYSIOLOGY SYSTEM
Applicant
Neuralynx, Inc.
105 Commercial Dr.
Bozeman,  MT  59715
Applicant Contact MIKE JOHNSON
Correspondent
Neuralynx, Inc.
105 Commercial Dr.
Bozeman,  MT  59715
Correspondent Contact MIKE JOHNSON
Regulation Number882.1400
Classification Product Code
OMC  
Date Received04/06/2011
Decision Date 06/30/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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