BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER

BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER is an FDA 510(k)-cleared medical device (K962103) 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 August 21, 1996. Regulation: 8.