OMRON, LUMISCOPE, LABTRON, MEDI - SOURCE, BAXTER

OMRON, LUMISCOPE, LABTRON, MEDI - SOURCE, BAXTER is an FDA 510(k)-cleared medical device (K955342) manufactured by Rashman Corp.. 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 16, 1996. Regulation: 8.