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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplitude-Integrated Electroencephalograph
510(k) Number K152301
Device Name Background Pattern Classification [BPc(TM)]
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
OMA  
Subsequent Product Code
ORT  
Date Received08/14/2015
Decision Date 06/03/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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