1ST RESPONSE REUSABLE MANUAL RESUSCITATOR (ADULT)

1ST RESPONSE REUSABLE MANUAL RESUSCITATOR (ADULT) is an FDA 510(k)-cleared medical device (K900577) manufactured by Intertech Resources, 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 July 15, 1990. Regulation: 8.