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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K093622
Device Name AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015
Applicant
Encision, Inc.
6797 Winchester Cir.
Boulder,  CO  80301
Applicant Contact JUDITH V KING
Correspondent
Encision, Inc.
6797 Winchester Cir.
Boulder,  CO  80301
Correspondent Contact JUDITH V KING
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/23/2009
Decision Date 08/20/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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