OHMEDA-OHIO CAE PLUS INCUBATOR

OHMEDA-OHIO CAE PLUS INCUBATOR is an FDA 510(k)-cleared medical device (K962806) manufactured by Ohmeda Medical. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 19, 1996. Regulation: 8.