SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE

SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE is an FDA 510(k)-cleared medical device (K860689) manufactured by Spacelabs, 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 July 29, 1986. Regulation: 8.