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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Non-Normalizing Quantitative Electroencephalograph Software
510(k) Number K940811
Device Name BRAINTRACE
Applicant
BRAINSTORMS MONITORING CORP.
1776 NORTH MOORPARK RD.
THOUSAND OAKS,  CA  91360
Applicant Contact DIEGO L GRU
Correspondent
BRAINSTORMS MONITORING CORP.
1776 NORTH MOORPARK RD.
THOUSAND OAKS,  CA  91360
Correspondent Contact DIEGO L GRU
Regulation Number882.1400
Classification Product Code
OLT  
Date Received02/22/1994
Decision Date 05/02/1995
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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