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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
Recalls CDRH Recalls
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