FDA 510(k)

Plum Duo Infusion System

K-Number: K223607 · 2023-08-24

Decision Date2023-08-24

Product CodeFRN

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Plum Duo Infusion System is a medical device manufactured by Icu Medical, Inc.. It received FDA 510(k) clearance on 2023-08-24 under approval number K223607. 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 Duo Infusion System?

Plum Duo Infusion System is a medical device that received FDA 510(k) clearance on 2023-08-24. It is manufactured by Icu Medical, Inc.. The 510(k) number is K223607.

When was Plum Duo Infusion System approved by the FDA?

Plum Duo Infusion System received FDA 510(k) clearance on 2023-08-24, under approval number K223607.

What company makes Plum Duo Infusion System?

Plum Duo Infusion System is manufactured by Icu Medical, Inc..

What is the FDA product code for Plum Duo Infusion System?

The FDA product code for Plum Duo Infusion System is FRN.

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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.