COMPANION 318 NASAL CPAP SYSTEM -- MODIFICATION

COMPANION 318 NASAL CPAP SYSTEM -- MODIFICATION is an FDA 510(k)-cleared medical device (K922178) 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 28, 1992. Regulation: 8.