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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 K172866
Device Name NeuroCap
Applicant
Memory MD, Inc.
205 E. 42nd St. 14th Floor
New York,  NY  10017
Applicant Contact Abdus-Salaam Muwwakkil
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
Suite 306, Kecheng Mansion, #121 Science Rd.
Guangzhou Science Park
Guangzhou,  CN 510006
Correspondent Contact Cassie Lee
Regulation Number882.1320
Classification Product Code
GXY  
Date Received09/20/2017
Decision Date 04/27/2018
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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