RESUBMITTAL OF MI 1000C MICROIMAGER

RESUBMITTAL OF MI 1000C MICROIMAGER is an FDA 510(k)-cleared medical device (K881979) manufactured by Ausonics Pty , 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 June 11, 1989. Regulation: 8.