COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM

COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM is an FDA 510(k)-cleared medical device (K910194) manufactured by Puritan Bennett 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 May 12, 1991. Regulation: 8.