BIOCHEM 520 BREATH INDICATOR

BIOCHEM 520 BREATH INDICATOR is an FDA 510(k)-cleared medical device (K890874) manufactured by Biochem International, 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 14, 1989. Regulation: 8.