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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 the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2023-07-26 under 510(k) 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. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K231038.

When did Global Hypoperfusion Index (GHI) Algorithm receive FDA 510(k) clearance?

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

Who is the listed applicant for Global Hypoperfusion Index (GHI) Algorithm?

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 Global Hypoperfusion Index (GHI) Algorithm?

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

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Other records listing Edwards Lifesciences, LLC as applicant

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Related Devices (Code: QNL)

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 →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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