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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 K030489
Device Name BRM2 BRAIN MONITOR
Applicant
Brainz Instruments , Ltd.
25 Carbine Rd. Mt. Wellington
P.O. Box 51-078, Paruranga
Auckland,  NZ
Applicant Contact CHRIS MANDER
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607
Correspondent Contact CHARLES MACK
Regulation Number882.1400
Classification Product Code
OLT  
Subsequent Product Code
OMC  
Date Received02/14/2003
Decision Date 05/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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