ICARE TONOMETER TA01I

ICARE TONOMETER TA01I is an FDA 510(k)-cleared medical device (K063873) manufactured by Tiolat OY. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 22, 2007. Regulation: 8.