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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 the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2018-11-30 under 510(k) 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. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K182245.

When did EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System receive FDA 510(k) clearance?

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

Who is the listed applicant for EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System?

The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: DXN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

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