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FDA 510(k)

HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform

Número K: K211465 · 2021-07-08

RequerenteEdwards Lfesciences
Data da decisão2021-07-08
Código do produtoDQK
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lfesciences. It received FDA 510(k) clearance on 2021-07-08 under 510(k) number K211465. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform?

HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform is a medical device that received FDA 510(k) clearance on 2021-07-08. The listed applicant is Edwards Lfesciences. The 510(k) number is K211465.

When did HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform receive FDA 510(k) clearance?

HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform received FDA 510(k) clearance on 2021-07-08, under 510(k) number K211465.

Who is the listed applicant for HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform?

The FDA 510(k) record lists Edwards Lfesciences as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform?

The FDA product code for HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform is DQK.

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Fonte oficial

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