OMNI-TRAK PATIENT MONITORING SYSTEM

OMNI-TRAK PATIENT MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K955045) 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 July 10, 1996. Regulation: 8.