FDA 510(k)

FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors

Número K: K242909 · 2025-03-21

Data da decisão2025-03-21

Código do produtoDRS

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors 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 2025-03-21 under 510(k) number K242909. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors?

FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors is a medical device that received FDA 510(k) clearance on 2025-03-21. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K242909.

When did FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors receive FDA 510(k) clearance?

FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors received FDA 510(k) clearance on 2025-03-21, under 510(k) number K242909.

Who is the listed applicant for FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors?

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 FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors?

The FDA product code for FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors is DRS.

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