510(k) K130690

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

K130690 is an FDA 510(k) premarket notification submitted by Zyno Medical, LLC for the device "Z-800 INFUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on June 12, 2013. 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.