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FDA 510(k)

Smart Wedge algorithm

K-Number: K230579 · 2023-08-18

ApplicantEdwards Lifesciences, LLC
Decision Date2023-08-18
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Smart Wedge algorithm is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2023-08-18 under approval number K230579. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Smart Wedge algorithm?

Smart Wedge algorithm is a medical device that received FDA 510(k) clearance on 2023-08-18. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K230579.

When was Smart Wedge algorithm approved by the FDA?

Smart Wedge algorithm received FDA 510(k) clearance on 2023-08-18, under approval number K230579.

What company makes Smart Wedge algorithm?

Smart Wedge algorithm is manufactured by Edwards Lifesciences, LLC.

What is the FDA product code for Smart Wedge algorithm?

The FDA product code for Smart Wedge algorithm is DQK.

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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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