HERCO SILICONE RESUSCITATOR OR SUN-MED RESUSCITA.

HERCO SILICONE RESUSCITATOR OR SUN-MED RESUSCITA. is an FDA 510(k)-cleared medical device (K875077) manufactured by Herco Products, 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 January 18, 1988. Regulation: 8.