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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 K102842
Device Name ADHESIVE ELECTRODES
Applicant
Reno Medical Limited
P.O. Box 237-023
Shanghai,  CN 200237
Applicant Contact Diana Hong
Correspondent
Reno Medical Limited
P.O. Box 237-023
Shanghai,  CN 200237
Correspondent Contact Diana Hong
Regulation Number882.1320
Classification Product Code
GXY  
Date Received09/29/2010
Decision Date 12/02/2010
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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