QUANTUM MODELS 253-09, 254-09 254-10

QUANTUM MODELS 253-09, 254-09 254-10 is an FDA 510(k)-cleared medical device (K820853) manufactured by Intermedics, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on April 8, 1982. Regulation: 8.