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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implantable Pacemaker Pulse-Generator
510(k) Number K896184
Device Name KALOS 05 PULSE GENERATOR
Applicant
Biotronik Cardiac Pacemakers
P.O. Box 1988
Lake Oswego,  CA  97034
Applicant Contact STOUT, MD
Correspondent
Biotronik Cardiac Pacemakers
P.O. Box 1988
Lake Oswego,  CA  97034
Correspondent Contact STOUT, MD
Regulation Number870.3610
Classification Product Code
DXY  
Date Received10/25/1989
Decision Date 01/18/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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