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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 K001069
Device Name MODEL 4000 EEG MONITOR WITH PSI (PSA4000)
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 Received04/03/2000
Decision Date 06/30/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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