MEMBRANE OXYGENATING SYS ADULT BMOS-7 & BMOS-3 PED

MEMBRANE OXYGENATING SYS ADULT BMOS-7 & BMOS-3 PED is an FDA 510(k)-cleared medical device (K854045) manufactured by American Bentley. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 15, 1985. Regulation: 8.