510(k) K153193

Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System) by Zyno Medical, LLC — Product Code FRN

K153193 is an FDA 510(k) premarket notification submitted by Zyno Medical, LLC for the device "Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)". The FDA issued a decision of Substantially Equivalent on August 30, 2016. 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.