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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Needle
510(k) Number K161566
Device Name DMS Disposable Subdermal Needle Electrodes
Applicant
Daehan Medical Systems Co., Ltd.
250 Okgucheondong-Ro
Siheung-City,  KR 15084
Applicant Contact Dong Cheul Kim
Correspondent
Daehan Medical Systems Co., Ltd.
250 Okgucheondong-Ro
Siheung-City,  KR 15084
Correspondent Contact Dong Cheul Kim
Regulation Number882.1350
Classification Product Code
GXZ  
Date Received06/06/2016
Decision Date 12/21/2016
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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