MEDTRONIC ENERTRAX MODEL 7100

MEDTRONIC ENERTRAX MODEL 7100 is an FDA 510(k)-cleared medical device (K822147) manufactured by Medtronic Vascular. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on August 5, 1982. Regulation: 8.