510(k) K100705

ZYNO Z-800 INFUSION SYSTEM MODEL Z-800 by Zyno Medical, LLC — Product Code FRN

K100705 is an FDA 510(k) premarket notification submitted by Zyno Medical, LLC for the device "ZYNO Z-800 INFUSION SYSTEM MODEL Z-800". The FDA issued a decision of Substantially Equivalent on July 8, 2010. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Zyno Medical, LLC has at least 6 other 510(k) clearances on record.