BABYSET TM & PAC TM -PULMONARY ASSIST

BABYSET TM & PAC TM -PULMONARY ASSIST is an FDA 510(k)-cleared medical device (K841264) manufactured by Life Design Systems, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 14, 1984. Regulation: 8.