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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 Avenue, Suite 1
Gainesville,  FL  32606
Applicant Contact J. Chris Sackellares
Correspondent
EncephaloDynamics, Inc.
4320 NW 23rd Avenue, 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
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