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FDA 510(k)

EV1000 Clinical Platform

K-Number: K193179 · 2019-12-17

ApplicantEdwards Lifesciences, LLC
Decision Date2019-12-17
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EV1000 Clinical Platform is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2019-12-17 under approval number K193179. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EV1000 Clinical Platform?

EV1000 Clinical Platform is a medical device that received FDA 510(k) clearance on 2019-12-17. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K193179.

When was EV1000 Clinical Platform approved by the FDA?

EV1000 Clinical Platform received FDA 510(k) clearance on 2019-12-17, under approval number K193179.

What company makes EV1000 Clinical Platform?

EV1000 Clinical Platform is manufactured by Edwards Lifesciences, LLC.

What is the FDA product code for EV1000 Clinical Platform?

The FDA product code for EV1000 Clinical Platform is DXG.

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Related PubMed Literature

PMID: 28005723 Light-Driven Contact Hearing Aid for Broad-Spectrum Amplification: Safety and Effectiveness Pivotal Study. Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology (2017)

Other Devices by Edwards Lifesciences, LLC

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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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