MODIFICATION MANUAL RESUSCITATOR (PMR 2)

MODIFICATION MANUAL RESUSCITATOR (PMR 2) is an FDA 510(k)-cleared medical device (K913370) manufactured by Puritan Bennett Corp.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 25, 1991. Regulation: 8.