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 a medical device manufactured by Eos Imaging, Inc.. It received FDA 510(k) clearance on 2016-04-22 under approval 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. It is manufactured by Eos Imaging, Inc.. The 510(k) number is K160914.
When was sterEOS Workstation approved by the FDA?
sterEOS Workstation received FDA 510(k) clearance on 2016-04-22, under approval number K160914.
What company makes sterEOS Workstation?
sterEOS Workstation is manufactured by Eos Imaging, Inc..
What is the FDA product code for sterEOS Workstation?
The FDA product code for sterEOS Workstation is LLZ.
Related Devices (Code: LLZ)
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.