OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM

OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K950688) manufactured by Safety Tek 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 April 17, 1996. Regulation: 8.