3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP

3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP is an FDA 510(k)-cleared medical device (K132967) manufactured by 3B Medical, 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 December 5, 2013. Regulation: 8.