SPIRO-LINK REAL TIME SPIROMETRY SYSTEM

SPIRO-LINK REAL TIME SPIROMETRY SYSTEM is an FDA 510(k)-cleared medical device (K892121) manufactured by Biocom Intl., Inc.. 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 15, 1989. Regulation: 8.