PULMANEX TM (NEO-NATAL SIZE)

PULMANEX TM (NEO-NATAL SIZE) is an FDA 510(k)-cleared medical device (K884068) manufactured by Life Design Systems, 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 November 15, 1988. Regulation: 8.