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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 Polysomnograph With Electroencephalograph
510(k) Number K090277
Device Name NATUS SLEEPWORKS, MODEL 104017
Applicant
EXCEL-TECH LTD. (XLTEK)
2568 BRISTOL CIR.
OAKVILLE, ONTARIO,  CA L6H 5S1
Applicant Contact GOLDY SINGH
Correspondent
EXCEL-TECH LTD. (XLTEK)
2568 BRISTOL CIR.
OAKVILLE, ONTARIO,  CA L6H 5S1
Correspondent Contact GOLDY SINGH
Regulation Number882.1400
Classification Product Code
OLZ  
Date Received02/04/2009
Decision Date 04/19/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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