COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE

COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE is an FDA 510(k)-cleared medical device (K980756) manufactured by Ge Medical Systems Information Technologies. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 4, 1998. Regulation: 8.