FDA 510(k)

Flo Trac sensor, Volume View sensor

Número K: K152980 · 2016-01-19

Data da decisão2016-01-19

Código do produtoDRS

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Flo Trac sensor, Volume View sensor 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 2016-01-19 under 510(k) number K152980. 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 Flo Trac sensor, Volume View sensor?

Flo Trac sensor, Volume View sensor is a medical device that received FDA 510(k) clearance on 2016-01-19. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K152980.

When did Flo Trac sensor, Volume View sensor receive FDA 510(k) clearance?

Flo Trac sensor, Volume View sensor received FDA 510(k) clearance on 2016-01-19, under 510(k) number K152980.

Who is the listed applicant for Flo Trac sensor, Volume View sensor?

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 Flo Trac sensor, Volume View sensor?

The FDA product code for Flo Trac sensor, Volume View sensor is DRS.

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Fonte oficial

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