ST-460 SPIRO ANALYZER SPIROMETER

ST-460 SPIRO ANALYZER SPIROMETER is an FDA 510(k)-cleared medical device (K852308) manufactured by Futuremed Div. of Future Impex 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 June 23, 1985. Regulation: 8.