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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K180524
Device Name EEG-Now
Applicant
Encephalodynamics, Inc.
4320 NW 23rd Ave., Suite 1
Gainesville,  FL  32606
Applicant Contact J. Chris Sackellares
Correspondent
Encephalodynamics, Inc.
4320 NW 23rd Ave., Suite 1
Gainesville,  FL  32606
Correspondent Contact J. Chris Sackellares
Regulation Number882.1320
Classification Product Code
GXY  
Date Received02/27/2018
Decision Date 05/18/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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