LiDCOunity v2 Hemodynamic Monitor— 510(k) K163334

Substantially Equivalent

Lidco, Ltd.

FDA 510(k) clearance K163334 for LiDCOunity v2 Hemodynamic Monitor, Substantially Equivalent on 2017-06-05. 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: 2016-11-28
Decision date: 2017-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: London, GB

Download summary PDF View on FDA.gov ↗

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More clearances from Lidco, Ltd.

K152935 — LiDCOunity Monitor2016-03-17
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

Recalls naming K163334

K-number listed on FDA's recall record

Z-0756-2021 — CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Product Usage: intended to administer lithium dilution indicator (tube administrative set).Class II·Terminated·Lidco Ltd·20201119

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K163334.

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