OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE

OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE is an FDA 510(k)-cleared medical device (K903186) manufactured by Telectronics Pacing Systems, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on January 17, 1991. Regulation: 8.