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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Pacemaker Generator Function, Indirect
510(k) Number K072950
Device Name CYGNUS 12 LEAD ECG MODULE
Applicant
Cygnus, LLC
510 E. 41st St.
Paterson,  NJ  07504
Applicant Contact NARCIS NAYDENOV
Correspondent
Cygnus, LLC
510 E. 41st St.
Paterson,  NJ  07504
Correspondent Contact NARCIS NAYDENOV
Regulation Number870.3640
Classification Product Code
KRE  
Date Received10/18/2007
Decision Date 08/22/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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