Name: Hypertension Prediction Index (HePI) Algorithm
Brand: Edwards Lifesciences, LLC
SKU: K242518

Hypertension Prediction Index (HePI) Algorithm is an FDA 510(k)-cleared medical device (K242518) manufactured by Edwards Lifesciences, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 14, 2025. Regulation: 8.

Hypertension Prediction Index (HePI) Algorithm

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