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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 K123079
Device Name OLYMPIC BRAINZ MONITOR
Applicant
EXCEL-TECH LTD. (XLTEK)
2568 BRISTOL CIR.
OAKVILLE, ONTARIO,  CA L6H 5S1
Applicant Contact DANIEL RAMIREZ
Correspondent
EXCEL-TECH LTD. (XLTEK)
2568 BRISTOL CIR.
OAKVILLE, ONTARIO,  CA L6H 5S1
Correspondent Contact DANIEL RAMIREZ
Regulation Number882.1400
Classification Product Code
OMA  
Subsequent Product Codes
OMB   OMC  
Date Received10/01/2012
Decision Date 05/08/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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