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FDA 510(k)

Acumen Hypotension Prediction Index (HPI) Algorithm

K-Number: K230057 · 2023-06-08

ApplicantEdwards Lifesciences, LLC
Decision Date2023-06-08
Product CodeQAQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Acumen Hypotension Prediction Index (HPI) Algorithm is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2023-06-08 under approval number K230057. The device is classified under product code QAQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Acumen Hypotension Prediction Index (HPI) Algorithm?

Acumen Hypotension Prediction Index (HPI) Algorithm is a medical device that received FDA 510(k) clearance on 2023-06-08. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K230057.

When was Acumen Hypotension Prediction Index (HPI) Algorithm approved by the FDA?

Acumen Hypotension Prediction Index (HPI) Algorithm received FDA 510(k) clearance on 2023-06-08, under approval number K230057.

What company makes Acumen Hypotension Prediction Index (HPI) Algorithm?

Acumen Hypotension Prediction Index (HPI) Algorithm is manufactured by Edwards Lifesciences, LLC.

What is the FDA product code for Acumen Hypotension Prediction Index (HPI) Algorithm?

The FDA product code for Acumen Hypotension Prediction Index (HPI) Algorithm is QAQ.

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Related Devices (Code: QAQ)

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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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