SORIN PULSE GENERATOR, MODEL #LIT-214

SORIN PULSE GENERATOR, MODEL #LIT-214 is an FDA 510(k)-cleared medical device (K801640) manufactured by Bentley Laboratories, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on October 2, 1980. Regulation: 8.