FDA 510(k)

Flo Trac sensor, Volume View sensor

K-Number: K152980 · 2016-01-19

Decision Date2016-01-19

Product CodeDRS

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

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.

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. 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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Related Devices (Code: DRS)

K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC K221782Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesMerit Medical Pte. , Ltd.K172458HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.K163172HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.K161408Compass Cast and MAPCenturion Medical Products Corporation K152472Disposable Pressure TransducerZhejiang Haisheng Medical Device Co., Ltd.

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.