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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 K172271
Device Name Trackit T4 EEG Amplifier
Applicant
Lifelines Ltd.
7 Clarendon Court
Over Wallop,  GB SO20 8HU
Applicant Contact Michael Hulin
Correspondent
Smith Associates
1468 Harwell Ave
Crofton,  MD  21114
Correspondent Contact Yolanda Smith
Regulation Number882.1400
Classification Product Code
GWQ  
Subsequent Product Code
GWL  
Date Received07/28/2017
Decision Date 05/04/2018
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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