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FDA 510(k)

EOSedge

K-Number: K202394 · 2020-09-16

ApplicantEos Imaging
Decision Date2020-09-16
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EOSedge is a medical device manufactured by Eos Imaging. It received FDA 510(k) clearance on 2020-09-16 under approval number K202394. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EOSedge?

EOSedge is a medical device that received FDA 510(k) clearance on 2020-09-16. It is manufactured by Eos Imaging. The 510(k) number is K202394.

When was EOSedge approved by the FDA?

EOSedge received FDA 510(k) clearance on 2020-09-16, under approval number K202394.

What company makes EOSedge?

EOSedge is manufactured by Eos Imaging.

What is the FDA product code for EOSedge?

The FDA product code for EOSedge is KPR.

Related Clinical Trials

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Related Devices (Code: KPR)

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.