SYRINGE SET, 3-WAY THERMODILUTIN

SYRINGE SET, 3-WAY THERMODILUTIN is an FDA 510(k)-cleared medical device (K760402) manufactured by Omp Laboratories, 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 August 22, 1976. Regulation: 8.