AS/3 CARDIAC OUTPUT & SVO2 MODULE

AS/3 CARDIAC OUTPUT & SVO2 MODULE is an FDA 510(k)-cleared medical device (K961063) manufactured by Datex Medical Instrumentation, 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 May 30, 1996. Regulation: 8.