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FDA 510(k)

Intraosseous infusion device

K-Number: K191258 · 2019-10-23

ApplicantEinstein Works, LLC
Decision Date2019-10-23
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Intraosseous infusion device is a medical device manufactured by Einstein Works, LLC. It received FDA 510(k) clearance on 2019-10-23 under approval number K191258. 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 Intraosseous infusion device?

Intraosseous infusion device is a medical device that received FDA 510(k) clearance on 2019-10-23. It is manufactured by Einstein Works, LLC. The 510(k) number is K191258.

When was Intraosseous infusion device approved by the FDA?

Intraosseous infusion device received FDA 510(k) clearance on 2019-10-23, under approval number K191258.

What company makes Intraosseous infusion device?

Intraosseous infusion device is manufactured by Einstein Works, LLC.

What is the FDA product code for Intraosseous infusion device?

The FDA product code for Intraosseous infusion device is FMI.

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Other Devices by Einstein Works, LLC

K182770Adult Intraosseous Infusion Device K211395NIO-I

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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.

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