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FDA 510(k)

LiDCOunity v2 Hemodynamic Monitor

K-Number: K163334 · 2017-06-05

ApplicantLidco, Ltd.
Decision Date2017-06-05
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LiDCOunity v2 Hemodynamic Monitor is a medical device manufactured by Lidco, Ltd.. It received FDA 510(k) clearance on 2017-06-05 under approval number K163334. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LiDCOunity v2 Hemodynamic Monitor?

LiDCOunity v2 Hemodynamic Monitor is a medical device that received FDA 510(k) clearance on 2017-06-05. It is manufactured by Lidco, Ltd.. The 510(k) number is K163334.

When was LiDCOunity v2 Hemodynamic Monitor approved by the FDA?

LiDCOunity v2 Hemodynamic Monitor received FDA 510(k) clearance on 2017-06-05, under approval number K163334.

What company makes LiDCOunity v2 Hemodynamic Monitor?

LiDCOunity v2 Hemodynamic Monitor is manufactured by Lidco, Ltd..

What is the FDA product code for LiDCOunity v2 Hemodynamic Monitor?

The FDA product code for LiDCOunity v2 Hemodynamic Monitor is DXG.

Related Clinical Trials

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Official Source

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