INVACARE POLARIS EX CPAP, MODEL ISP3000

INVACARE POLARIS EX CPAP, MODEL ISP3000 is an FDA 510(k)-cleared medical device (K031064) manufactured by Invacare 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 March 11, 2004. Regulation: 8.