BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR

BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR is an FDA 510(k)-cleared medical device (K934310) manufactured by Respironics, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 13, 1993. Regulation: 8.