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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 Full-Montage Electroencephalograph
510(k) Number K200878
Device Name Natus NeuroWorks
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
OMB  
Subsequent Product Codes
OLT   OMA  
Date Received04/02/2020
Decision Date 05/18/2020
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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