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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplitude-Integrated Electroencephalograph
510(k) Number K071449
Device Name BRM3 BRAIN MONITOR
Applicant
BRAINZ INSTRUMENTS LTD.
25 CARBINE ROAD MT. WELLINGTON
PO BOX 51-078, PARURANGA
AUCKLAND,  NZ
Applicant Contact CHRIS MANDER
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Correspondent Contact MORTEN SIMON CHRISTENSEN
Regulation Number882.1400
Classification Product Code
OMA  
Subsequent Product Codes
OLT   OMC  
Date Received05/24/2007
Decision Date 09/14/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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