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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 K163547
Device Name MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96
Applicant
Neurovirtual USA, Inc.
2315 NW 107th Ave. Suite# 1m27
Doral,  FL  33172
Applicant Contact Eduardo Faria
Correspondent
Neurovirtual USA, Inc.
2315 NW 107th Ave. Suite# 1m27
Doral,  FL  33172
Correspondent Contact Eduardo Faria
Regulation Number882.1320
Classification Product Code
GXY  
Date Received12/16/2016
Decision Date 04/11/2017
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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