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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
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