E100M VENTILATOR (E100M)

E100M VENTILATOR (E100M) is an FDA 510(k)-cleared medical device (K972833) manufactured by Newport Medical Instruments, 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 September 22, 1999. Regulation: 8.