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FDA 510(k)

sterEOS Workstation

K-Number: K160914 · 2016-04-22

ApplicantEos Imaging, Inc.
Decision Date2016-04-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

sterEOS Workstation is the device name listed in this FDA 510(k) record. The listed applicant is Eos Imaging, Inc.. It received FDA 510(k) clearance on 2016-04-22 under 510(k) number K160914. 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 2016-04-22. The listed applicant is Eos Imaging, Inc.. The 510(k) number is K160914.

When did sterEOS Workstation receive FDA 510(k) clearance?

sterEOS Workstation received FDA 510(k) clearance on 2016-04-22, under 510(k) number K160914.

Who is the listed applicant for sterEOS Workstation?

The FDA 510(k) record lists Eos Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for sterEOS Workstation?

The FDA product code for sterEOS Workstation is LLZ.

Other records listing Eos Imaging, Inc. as applicant

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Related Devices (Code: LLZ)

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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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