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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 K033010
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.
1655 Scott Blvd.
Santa Clara,  CA  95050
Correspondent Contact DENISE L KLINKER
Regulation Number882.1400
Classification Product Code
OLT  
Subsequent Product Codes
GXY   OMC  
Date Received09/26/2003
Decision Date 10/10/2003
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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