OHMEDA INFANT RESUSCITATION SYSTEM

OHMEDA INFANT RESUSCITATION SYSTEM is an FDA 510(k)-cleared medical device (K971243) manufactured by Ohmeda Medical. 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 1, 1997. Regulation: 8.