SORIN PULSE GENERATOR MODEL # LIT 214 H

SORIN PULSE GENERATOR MODEL # LIT 214 H is an FDA 510(k)-cleared medical device (K792565) 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 February 4, 1980. Regulation: 8.