SHERIDAN - YSI/ECG SONATEMP (TM)

SHERIDAN - YSI/ECG SONATEMP (TM) is an FDA 510(k)-cleared medical device (K861541) manufactured by Sheridan Catheter Corp.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 15, 1986. Regulation: 8.