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FDA 510(k)

Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module

K-Number: K161469 · 2017-03-28

ApplicantHospira, Inc.
Decision Date2017-03-28
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module is a medical device manufactured by Hospira, Inc.. It received FDA 510(k) clearance on 2017-03-28 under approval number K161469. 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 Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module?

Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module is a medical device that received FDA 510(k) clearance on 2017-03-28. It is manufactured by Hospira, Inc.. The 510(k) number is K161469.

When was Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module approved by the FDA?

Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module received FDA 510(k) clearance on 2017-03-28, under approval number K161469.

What company makes Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module?

Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module is manufactured by Hospira, Inc..

What is the FDA product code for Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module?

The FDA product code for Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module is FRN.

Related Clinical Trials

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Other Devices by Hospira, Inc.

K160492Hospira Sapphire Sets K160870Hospira Administration Sets K143612LifeCare PCA Infusion System K161036Hospira Extension Set, Hospira Primary Set

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 K161667Sapphire Infusion PumpQ Core Medical , Ltd. 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.

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