LiDCOunity Monitor— 510(k) K152935

Substantially Equivalent

Lidco, Ltd.

FDA 510(k) clearance K152935 for LiDCOunity Monitor, Substantially Equivalent on 2016-03-17. Applicant: Lidco, Ltd.. Device class: 2.

Clearance details

Applicant: Lidco, Ltd.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 2015-10-05
Decision date: 2016-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: London, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code DXG

K253092 — Argos Infinity (Rev. 1.0)2026-02-13
K251275 — VitalStream ART Connect; VitalStream-Hemo2025-09-26
K232048 — Cogent Hemodynamic Monitoring System; Cogent HMS2023-12-20
K212529 — Hypotension Decision Assist Model HDA-OR22021-11-23
K192169 — PulsioFlex Monitoring System with ProAQT Sensor2020-04-30

More clearances from Lidco, Ltd.

K163334 — LiDCOunity v2 Hemodynamic Monitor2017-06-05
K131048 — LIDCO CNAP MODULE2013-08-28
K122247 — LIDCORAPID V2 MONITOR2013-03-20
K023960 — LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 702003-01-09
K010049 — PULSECO HEMODYNAMIC MONITOR CM712001-06-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.