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FDA 510(k)

Acumen IQ finger cuff

K-Number: K230919 · 2023-10-24

ApplicantEdwards Lifesciences, LLC
Decision Date2023-10-24
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Acumen IQ finger cuff is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2023-10-24 under approval number K230919. 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 Acumen IQ finger cuff?

Acumen IQ finger cuff is a medical device that received FDA 510(k) clearance on 2023-10-24. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K230919.

When was Acumen IQ finger cuff approved by the FDA?

Acumen IQ finger cuff received FDA 510(k) clearance on 2023-10-24, under approval number K230919.

What company makes Acumen IQ finger cuff?

Acumen IQ finger cuff is manufactured by Edwards Lifesciences, LLC.

What is the FDA product code for Acumen IQ finger cuff?

The FDA product code for Acumen IQ finger cuff is DXN.

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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