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FDA 510(k)

EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System

K-Number: K182245 · 2018-11-30

ApplicantEdwards Lifesciences, LLC
Decision Date2018-11-30
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2018-11-30 under approval number K182245. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System?

EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System is a medical device that received FDA 510(k) clearance on 2018-11-30. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K182245.

When was EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System approved by the FDA?

EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System received FDA 510(k) clearance on 2018-11-30, under approval number K182245.

What company makes EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System?

EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System is manufactured by Edwards Lifesciences, LLC.

What is the FDA product code for EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System?

The FDA product code for EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System is DXN.

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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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