NORMOCAP CR-102, RECORDER UNIT

NORMOCAP CR-102, RECORDER UNIT is an FDA 510(k)-cleared medical device (K802762) manufactured by Instrumentarium-Datex. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 25, 1980. Regulation: 8.