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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source Localization Software For Electroencephalograph Or Magnetoencephalograph
510(k) Number K201910
Device Name EZTrack
Applicant
Neurologic, LLC
6500 Tucker Ave.
Mclean,  VA  22101
Applicant Contact Sridevi Sarma
Correspondent
Biologics Consulting
1555 King St.
Alexandri,  VA  22314
Correspondent Contact Joshua Crist
Regulation Number882.1400
Classification Product Code
OLX  
Date Received07/09/2020
Decision Date 12/22/2020
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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