TESLAOXYSAT, MODEL EFOXYSATE

TESLAOXYSAT, MODEL EFOXYSATE is an FDA 510(k)-cleared medical device (K050018) manufactured by Mammendorfer Institute For Physics & Medicine GmbH. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 30, 2005. Regulation: 8.