FDA 510(k)

NIO-I

K-Number: K211395 · 2021-07-28

Decision Date2021-07-28

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NIO-I is a medical device manufactured by Einstein Works, LLC. It received FDA 510(k) clearance on 2021-07-28 under approval number K211395. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIO-I?

NIO-I is a medical device that received FDA 510(k) clearance on 2021-07-28. It is manufactured by Einstein Works, LLC. The 510(k) number is K211395.

When was NIO-I approved by the FDA?

NIO-I received FDA 510(k) clearance on 2021-07-28, under approval number K211395.

What company makes NIO-I?

NIO-I is manufactured by Einstein Works, LLC.

What is the FDA product code for NIO-I?

The FDA product code for NIO-I is FMI.

Other Devices by Einstein Works, LLC

K191258Intraosseous infusion device K182770Adult Intraosseous Infusion Device

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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.