PFT SCREENER (SYSTEM 1100)

PFT SCREENER (SYSTEM 1100) is an FDA 510(k)-cleared medical device (K812792) manufactured by Medical Graphics 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 November 26, 1981. Regulation: 8.