FDA 510(k)

Hypertension Prediction Index (HePI) Algorithm

Número K: K242518 · 2025-05-15

Data da decisão2025-05-15

Código do produtoQAQ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Hypertension Prediction Index (HePI) 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 2025-05-15 under 510(k) number K242518. The device is classified under product code QAQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K242518.

When did Hypertension Prediction Index (HePI) Algorithm receive FDA 510(k) clearance?

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

Who is the listed applicant for Hypertension Prediction Index (HePI) 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 Hypertension Prediction Index (HePI) Algorithm?

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

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Dispositivos Relacionados (Código: QAQ)

K230057Algoritmo de Índice de Hipotensão Predictiva (HPI) AcumenEdwards Lifesciences, LLC K203224Índice de Predição de Hipotensão Acumen, Plataforma de Monitoramento Avançado HemoSphereEdwards Lifesciences, LLC K183646Plataforma Clínica EV1000 de Índice de Hipotensão Predictiva (HPI) Acumen, Plataforma de Monitoramento Avançado HemoSphere de Índice de Hipotensão Predictiva (HPI), Plataforma de Monitoramento Avançado HemoSphere - PressãoEdwards Lifeciences, LLC

Fonte oficial

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