FDA 510(k)

Sapphire Infusion Pump

K-Number: K161667 · 2017-03-27

Decision Date2017-03-27

Product CodeFRN

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Sapphire Infusion Pump is a medical device manufactured by Q Core Medical , Ltd.. It received FDA 510(k) clearance on 2017-03-27 under approval number K161667. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sapphire Infusion Pump?

Sapphire Infusion Pump is a medical device that received FDA 510(k) clearance on 2017-03-27. It is manufactured by Q Core Medical , Ltd.. The 510(k) number is K161667.

When was Sapphire Infusion Pump approved by the FDA?

Sapphire Infusion Pump received FDA 510(k) clearance on 2017-03-27, under approval number K161667.

What company makes Sapphire Infusion Pump?

Sapphire Infusion Pump is manufactured by Q Core Medical , Ltd..

What is the FDA product code for Sapphire Infusion Pump?

The FDA product code for Sapphire Infusion Pump is FRN.

Other Devices by Q Core Medical , Ltd.

K192860Sapphire Infusion Pump, Sapphire administration sets

Related Devices (Code: FRN)

K143369MRidium 3860+ MRI infusion Pump/ Monitoring SystemIradimed Corporation K153599Concert Medical Hands-Free Syringe (HFS)Concert Medical, LLC K153193Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)Zyno Medical, LLC K162613Integrated Catch-up Freedom Syringe Driver Infusion SystemRepro-Med Systems, Inc. Dba Rms Medical Products K161469Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleHospira, Inc. K172653Power InfuserZOLL Medical Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.