MEDTRONIC 3625 SCREENER SYSTEM

MEDTRONIC 3625 SCREENER SYSTEM is an FDA 510(k)-cleared medical device (K913442) manufactured by Medtronic Vascular. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 21, 1991. Regulation: 8.