SPIROLITE MODEL MSC-201 SPIROMETER

SPIROLITE MODEL MSC-201 SPIROMETER is an FDA 510(k)-cleared medical device (K921513) manufactured by Medical Systems 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 January 26, 1993. Regulation: 8.