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FDA 510(k)

Global Hypoperfusion Index (GHI) Algorithm

K-Number: K231038 · 2023-07-26

ApplicantEdwards Lifesciences, LLC
Decision Date2023-07-26
Product CodeQNL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Global Hypoperfusion Index (GHI) Algorithm is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2023-07-26 under approval number K231038. The device is classified under product code QNL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Global Hypoperfusion Index (GHI) Algorithm?

Global Hypoperfusion Index (GHI) Algorithm is a medical device that received FDA 510(k) clearance on 2023-07-26. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K231038.

When was Global Hypoperfusion Index (GHI) Algorithm approved by the FDA?

Global Hypoperfusion Index (GHI) Algorithm received FDA 510(k) clearance on 2023-07-26, under approval number K231038.

What company makes Global Hypoperfusion Index (GHI) Algorithm?

Global Hypoperfusion Index (GHI) Algorithm is manufactured by Edwards Lifesciences, LLC.

What is the FDA product code for Global Hypoperfusion Index (GHI) Algorithm?

The FDA product code for Global Hypoperfusion Index (GHI) Algorithm is QNL.

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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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