RESPICENTRAL(TM)

RESPICENTRAL(TM) is an FDA 510(k)-cleared medical device (K863538) manufactured by Dickstein, Shapiro & Morin. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 23, 1986. Regulation: 8.