BIOSURGE MODEL OASYS-II

BIOSURGE MODEL OASYS-II is an FDA 510(k)-cleared medical device (K875023) manufactured by Biosurge, 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 February 11, 1988. Regulation: 8.