OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM

OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K971840) manufactured by Invivo Research, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 3, 1998. Regulation: 8.