ZYNO Z-800 INFUSION SYSTEM MODEL Z-800

ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 is an FDA 510(k)-cleared medical device (K100705) manufactured by Zyno Medical, LLC. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 7, 2010. Regulation: 8.