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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplifier, Physiological Signal
510(k) Number K151600
Device Name R-40 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 Number882.1835
Classification Product Code
GWL  
Subsequent Product Code
GWQ  
Date Received06/12/2015
Decision Date 10/23/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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