Eko CORE
K-Number: K200776 · 2020-04-06
ApplicantEko Devices, Inc.
Decision Date2020-04-06
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Eko CORE is a medical device manufactured by Eko Devices, Inc.. It received FDA 510(k) clearance on 2020-04-06 under approval number K200776. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Eko CORE?
Eko CORE is a medical device that received FDA 510(k) clearance on 2020-04-06. It is manufactured by Eko Devices, Inc.. The 510(k) number is K200776.
When was Eko CORE approved by the FDA?
Eko CORE received FDA 510(k) clearance on 2020-04-06, under approval number K200776.
What company makes Eko CORE?
Eko CORE is manufactured by Eko Devices, Inc..
What is the FDA product code for Eko CORE?
The FDA product code for Eko CORE is DQD.
Other Devices by Eko Devices, Inc.
Related Devices (Code: DQD)
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.