NARCO AIR-SHEILDS SYS. 100 MONITOR SYS

NARCO AIR-SHEILDS SYS. 100 MONITOR SYS is an FDA 510(k)-cleared medical device (K802800) manufactured by Narco Air-Shields. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 23, 1980. Regulation: 8.