FDA 510(k)

Rio Vial-to-Bag Drug Reconstitution Device

K-Number: K192154 · 2020-04-20

Decision Date2020-04-20

Product CodeLHI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Rio Vial-to-Bag Drug Reconstitution Device is a medical device manufactured by Icu Medical. It received FDA 510(k) clearance on 2020-04-20 under approval number K192154. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rio Vial-to-Bag Drug Reconstitution Device?

Rio Vial-to-Bag Drug Reconstitution Device is a medical device that received FDA 510(k) clearance on 2020-04-20. It is manufactured by Icu Medical. The 510(k) number is K192154.

When was Rio Vial-to-Bag Drug Reconstitution Device approved by the FDA?

Rio Vial-to-Bag Drug Reconstitution Device received FDA 510(k) clearance on 2020-04-20, under approval number K192154.

What company makes Rio Vial-to-Bag Drug Reconstitution Device?

Rio Vial-to-Bag Drug Reconstitution Device is manufactured by Icu Medical.

What is the FDA product code for Rio Vial-to-Bag Drug Reconstitution Device?

The FDA product code for Rio Vial-to-Bag Drug Reconstitution Device is LHI.

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Official Source

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