PRECISION ONE LIFECARE; DETECTO; DETECTO

PRECISION ONE LIFECARE; DETECTO; DETECTO is an FDA 510(k)-cleared medical device (K130952) manufactured by Precision One Lifecare, Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 25, 2013. Regulation: 8.