FDA 510(k)

Índice de Predição de Hipotensão Acumen, Plataforma de Monitoramento Avançado HemoSphere

Número K: K203224 · 2021-07-30

Data da decisão2021-07-30

Código do produtoQAQ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform 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 2021-07-30 under 510(k) number K203224. 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 Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform?

Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform is a medical device that received FDA 510(k) clearance on 2021-07-30. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K203224.

When did Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform receive FDA 510(k) clearance?

Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform received FDA 510(k) clearance on 2021-07-30, under 510(k) number K203224.

Who is the listed applicant for Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform?

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 Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform?

The FDA product code for Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform is QAQ.

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Outros registros que listam Edwards Lifesciences, LLC como candidato(a)

K251326Respiration Rate algorithm K253186HemoSphere Nano Monitor (HSNANO1)K251982Edwards MC3 Tricuspid annuloplasty ring (4900)K251688Carpentier-Edwards Physio Annuloplasty Ring (4450)K242518Hypertension Prediction Index (HePI) Algorithm K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors

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Dispositivos Relacionados (Código: QAQ)

K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC K230057Algoritmo de Índice de Hipotensão Predictiva (HPI) AcumenEdwards 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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