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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 K143440
Device Name Natus Quantum
Applicant
NATUS MEDICAL INCORPORATED
DBA EXCEL-TECH LTD (XLTEK)
2568 BRISTOL CIRCLE
OAKVILLE,  CA L6H 5S1
Applicant Contact SANJAY MEHTA
Correspondent
NATUS MEDICAL INCORPORATED
DBA EXCEL-TECH LTD (XLTEK)
2568 BRISTOL CIRCLE
OAKVILLE,  CA L6H 5S1
Correspondent Contact SANJAY MEHTA
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Codes
GYC   OLV  
Date Received12/02/2014
Decision Date 04/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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