IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006

IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006 is an FDA 510(k)-cleared medical device (K992057) manufactured by Sims Portex, 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 September 12, 1999. Regulation: 8.