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FDA 510(k)

Eko Model E5 System (EME5), Eko DUO

K-Number: K170874 · 2017-05-19

ApplicantEko Devices, Inc.
Decision Date2017-05-19
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Eko Model E5 System (EME5), Eko DUO is a medical device manufactured by Eko Devices, Inc.. It received FDA 510(k) clearance on 2017-05-19 under approval number K170874. 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 Model E5 System (EME5), Eko DUO?

Eko Model E5 System (EME5), Eko DUO is a medical device that received FDA 510(k) clearance on 2017-05-19. It is manufactured by Eko Devices, Inc.. The 510(k) number is K170874.

When was Eko Model E5 System (EME5), Eko DUO approved by the FDA?

Eko Model E5 System (EME5), Eko DUO received FDA 510(k) clearance on 2017-05-19, under approval number K170874.

What company makes Eko Model E5 System (EME5), Eko DUO?

Eko Model E5 System (EME5), Eko DUO is manufactured by Eko Devices, Inc..

What is the FDA product code for Eko Model E5 System (EME5), Eko DUO?

The FDA product code for Eko Model E5 System (EME5), Eko DUO is DQD.

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Other Devices by Eko Devices, Inc.

K200776Eko CORE K192004Eko Analysis Software K213794Eko Murmur Analysis Software (EMAS) K230111CORE 500 Digital Stethoscope

Related Devices (Code: DQD)

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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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