
Medtronic Hemotec, Inc.
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MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER is an FDA 510(k)-cleared medical device (K940426) manufactured by Medtronic Hemotec, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 19, 1994. Regulation: 8.