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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name automatic event detection software for full-montage electroencephalograph
510(k) Number K042223
Device Name XLTEK CONNEX IP HEADBOX, MODEL 1054
Applicant
EXCEL TECH. LTD.
2568 BRISTOL CIRCLE
OAKVILLE, ONTARIO,  CA L6H 5S1
Applicant Contact NICOLE LANDREVILLE
Correspondent
EXCEL TECH. LTD.
2568 BRISTOL CIRCLE
OAKVILLE, ONTARIO,  CA L6H 5S1
Correspondent Contact NICOLE LANDREVILLE
Regulation Number882.1400
Classification Product Code
OMB  
Subsequent Product Codes
OLT   OLV   OLZ  
Date Received08/17/2004
Decision Date 09/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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