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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 the device name listed in this FDA 510(k) record. The listed applicant is Lidco, Ltd.. It received FDA 510(k) clearance on 2016-03-17 under 510(k) 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. The listed applicant is Lidco, Ltd.. The 510(k) number is K152935.

When did LiDCOunity Monitor receive FDA 510(k) clearance?

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

Who is the listed applicant for LiDCOunity Monitor?

The FDA 510(k) record lists Lidco, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LiDCOunity Monitor?

The FDA product code for LiDCOunity Monitor is DXG.

Other records listing Lidco, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K163334LiDCOunity v2 Hemodynamic Monitor

Related Devices (Code: DXG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253092Argos Infinity (Rev. 1.0)Retia Medical Systems, Inc.K251275VitalStream ART Connect; VitalStream-HemoCaretaker MedicalK232048Cogent™ Hemodynamic Monitoring System; Cogent™ HMSIcu MedicalK212529Hypotension Decision Assist Model HDA-OR2Directed Systems, Ltd.K192169PulsioFlex Monitoring System with ProAQT SensorPulsion Medical Systems SEK193179EV1000 Clinical PlatformEdwards Lifesciences, LLC

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.

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