PEDIA-TRAKE CRICOTHYROTOMY KIT

PEDIA-TRAKE CRICOTHYROTOMY KIT is an FDA 510(k)-cleared medical device (K840925) manufactured by Intl. Medical Devices , Ltd.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 1, 1984. Regulation: 8.