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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 K903186
Device Name OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE
Applicant
Telectronics Pacing Systems, Inc.
7400 S. Tucson Way
Englewood,  CO  80112
Applicant Contact DUANE A SCHULTZ
Correspondent
Telectronics Pacing Systems, Inc.
7400 S. Tucson Way
Englewood,  CO  80112
Correspondent Contact DUANE A SCHULTZ
Regulation Number870.3610
Classification Product Code
DXY  
Date Received07/19/1990
Decision Date 01/18/1991
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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