DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX

DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX is an FDA 510(k)-cleared medical device (K012531) manufactured by Datex-Ohmeda. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 1, 2001. Regulation: 8.