FusedCO Algorithm
K-Number: K231035 · 2023-07-12
ApplicantEdwards Lifesciences, LLC
Decision Date2023-07-12
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
FusedCO Algorithm is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2023-07-12 under approval number K231035. 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 FusedCO Algorithm?
FusedCO Algorithm is a medical device that received FDA 510(k) clearance on 2023-07-12. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K231035.
When was FusedCO Algorithm approved by the FDA?
FusedCO Algorithm received FDA 510(k) clearance on 2023-07-12, under approval number K231035.
What company makes FusedCO Algorithm?
FusedCO Algorithm is manufactured by Edwards Lifesciences, LLC.
What is the FDA product code for FusedCO Algorithm?
The FDA product code for FusedCO 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.