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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name index-generating electroencephalograph software
510(k) Number K020671
Device Name PSA4000 EEG MONITOR WITH FRONTAL PSI
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
OLW  
Subsequent Product Codes
OMC   ORT  
Date Received03/01/2002
Decision Date 10/04/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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