ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD.

ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD. is an FDA 510(k)-cleared medical device (K930790) manufactured by Bio-Logic 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 5, 1994. Regulation: 8.