SYSTEM 82 COMPUTERIZED LUNG VO. SPIRO

SYSTEM 82 COMPUTERIZED LUNG VO. SPIRO is an FDA 510(k)-cleared medical device (K801918) manufactured by Pulmonary Testing Systems. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 2, 1980. Regulation: 8.