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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 the device name listed in this FDA 510(k) record. The listed applicant is Einstein Works, LLC. It received FDA 510(k) clearance on 2019-04-09 under 510(k) 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. The listed applicant is Einstein Works, LLC. The 510(k) number is K182770.

When did Adult Intraosseous Infusion Device receive FDA 510(k) clearance?

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

Who is the listed applicant for Adult Intraosseous Infusion Device?

The FDA 510(k) record lists Einstein Works, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Einstein Works, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211395NIO-IK191258Intraosseous infusion device

Related Devices (Code: FMI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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