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FDA 510(k)

Adult Intraosseous Infusion Device

K-Number: K182770 · 2019-04-09

ApplicantEinstein Works, LLC
Decision Date2019-04-09
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Adult Intraosseous Infusion Device is a medical device manufactured by Einstein Works, LLC. It received FDA 510(k) clearance on 2019-04-09 under approval number K182770. 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 Adult Intraosseous Infusion Device?

Adult Intraosseous Infusion Device is a medical device that received FDA 510(k) clearance on 2019-04-09. It is manufactured by Einstein Works, LLC. The 510(k) number is K182770.

When was Adult Intraosseous Infusion Device approved by the FDA?

Adult Intraosseous Infusion Device received FDA 510(k) clearance on 2019-04-09, under approval number K182770.

What company makes Adult Intraosseous Infusion Device?

Adult Intraosseous Infusion Device is manufactured by Einstein Works, LLC.

What is the FDA product code for Adult Intraosseous Infusion Device?

The FDA product code for Adult Intraosseous Infusion Device is FMI.

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Other Devices by Einstein Works, LLC

K191258Intraosseous infusion device K211395NIO-I

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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.

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