EMS MOUTH TO MASK RESUSCITATORS

EMS MOUTH TO MASK RESUSCITATORS is an FDA 510(k)-cleared medical device (K983919) manufactured by Engineered Medical Systems. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 6, 1999. Regulation: 8.