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FDA 510(k)

Flo Trac sensor, Volume View sensor

K-Number: K152980 · 2016-01-19

ApplicantEdwards Lifesciences, LLC
Decision Date2016-01-19
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Flo Trac sensor, Volume View sensor is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2016-01-19 under approval number K152980. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K152980.

When was Flo Trac sensor, Volume View sensor approved by the FDA?

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

What company makes Flo Trac sensor, Volume View sensor?

Flo Trac sensor, Volume View sensor is manufactured by Edwards Lifesciences, LLC.

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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