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FDA 510(k)

sterEOS Workstation

K-Number: K172346 · 2018-06-19

ApplicantEos Imaging
Decision Date2018-06-19
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

sterEOS Workstation is a medical device manufactured by Eos Imaging. It received FDA 510(k) clearance on 2018-06-19 under approval number K172346. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the sterEOS Workstation?

sterEOS Workstation is a medical device that received FDA 510(k) clearance on 2018-06-19. It is manufactured by Eos Imaging. The 510(k) number is K172346.

When was sterEOS Workstation approved by the FDA?

sterEOS Workstation received FDA 510(k) clearance on 2018-06-19, under approval number K172346.

What company makes sterEOS Workstation?

sterEOS Workstation is manufactured by Eos Imaging.

What is the FDA product code for sterEOS Workstation?

The FDA product code for sterEOS Workstation is LLZ.

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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.