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FDA 510(k)

Hypertension Prediction Index (HePI) Algorithm

K-Number: K242518 · 2025-05-15

ApplicantEdwards Lifesciences, LLC
Decision Date2025-05-15
Product CodeQAQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Hypertension Prediction Index (HePI) Algorithm is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2025-05-15 under approval number K242518. 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 Hypertension Prediction Index (HePI) Algorithm?

Hypertension Prediction Index (HePI) Algorithm is a medical device that received FDA 510(k) clearance on 2025-05-15. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K242518.

When was Hypertension Prediction Index (HePI) Algorithm approved by the FDA?

Hypertension Prediction Index (HePI) Algorithm received FDA 510(k) clearance on 2025-05-15, under approval number K242518.

What company makes Hypertension Prediction Index (HePI) Algorithm?

Hypertension Prediction Index (HePI) Algorithm is manufactured by Edwards Lifesciences, LLC.

What is the FDA product code for Hypertension Prediction Index (HePI) Algorithm?

The FDA product code for Hypertension Prediction Index (HePI) Algorithm is 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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