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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 K962447
Device Name EQUINOX DIGITAL EEG 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 Received06/24/1996
Decision Date 12/12/1996
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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