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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K970942
Device Name MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM
Applicant
PHYSIOMETRIX, INC.
FIVE BILLERICA PARK,
101 BILLERICA AVE.
NORTH BILLERICA,  MA  01862
Applicant Contact DAWN E FRAZER
Correspondent
PHYSIOMETRIX, INC.
FIVE BILLERICA PARK,
101 BILLERICA AVE.
NORTH BILLERICA,  MA  01862
Correspondent Contact DAWN E FRAZER
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received03/14/1997
Decision Date 06/02/1997
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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