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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K082380
Device Name VICARDIO 12B
Applicant
Energy-Lab Technologies GmbH
377 Rte. 17
Hasbrouck Heights,  NJ  07604
Applicant Contact GEORGE MYERS
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462
Correspondent Contact ROBERT MOSENKIS
Regulation Number870.2340
Classification Product Code
DPS  
Date Received08/19/2008
Decision Date 12/03/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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