Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LiDCOunity Monitor

K-Number: K152935 · 2016-03-17

ApplicantLidco, Ltd.
Decision Date2016-03-17
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LiDCOunity Monitor is a medical device manufactured by Lidco, Ltd.. It received FDA 510(k) clearance on 2016-03-17 under approval number K152935. 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 Monitor?

LiDCOunity Monitor is a medical device that received FDA 510(k) clearance on 2016-03-17. It is manufactured by Lidco, Ltd.. The 510(k) number is K152935.

When was LiDCOunity Monitor approved by the FDA?

LiDCOunity Monitor received FDA 510(k) clearance on 2016-03-17, under approval number K152935.

What company makes LiDCOunity Monitor?

LiDCOunity Monitor is manufactured by Lidco, Ltd..

What is the FDA product code for LiDCOunity Monitor?

The FDA product code for LiDCOunity Monitor is DXG.

Other Devices by Lidco, Ltd.

K163334LiDCOunity v2 Hemodynamic Monitor

Related Devices (Code: DXG)

K163334LiDCOunity v2 Hemodynamic MonitorLidco, Ltd. K181372ArgosRetia Medical, LLC K172259PulsioFlex Monitoring SystemPulsion Medical Systems SE K193179EV1000 Clinical PlatformEdwards Lifesciences, LLC K190955Hypotension Decision AssistDirected Systems, Ltd. K192169PulsioFlex Monitoring System with ProAQT SensorPulsion Medical Systems SE

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.

↑