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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K100683
Device Name NEUROLINK IP MODEL: PK1117
Applicant
NATUS MEDICAL INCORPORATED
DBA EXCEL-TECH LTD (XLTEK)
2568 BRISTOL CIRCLE
OAKVILLE, ONTARIO,  CA L6H 5S1
Applicant Contact GOLDY SINGH
Correspondent
NATUS MEDICAL INCORPORATED
DBA EXCEL-TECH LTD (XLTEK)
2568 BRISTOL CIRCLE
OAKVILLE, ONTARIO,  CA L6H 5S1
Correspondent Contact GOLDY SINGH
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received03/10/2010
Decision Date 04/09/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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