DATEX-OHMEDA NE12STPR MODULE (MODEL FAMILY M-NE12STPR)

DATEX-OHMEDA NE12STPR MODULE (MODEL FAMILY M-NE12STPR) is an FDA 510(k)-cleared medical device (K993608) manufactured by Datex-Ohmeda, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 12, 2000. Regulation: 8.