Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617127

FEI Number

3001139253

Entity Name

LIDCO LTD.

City/State/Country

LONDON England, GB

Establishment Address

Unit D4, Tottenham Commercial Park, Leeside Road, LONDON England N17 0QJ, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LIDCO LTD. (Owner Number: 9036223)

Owner / Operator Contact Address

Unit D4,, Tottenham Commercial Park, Leeside Road, LONDON, GB-ENG N17 0QJ, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K152935

PMA Number

N/A

All Registered Proprietary Names

LiDCOunity v2 Monitor LiDCOunity v2 Hemodynamic Monitoring System LiDCO PulseCO Hemodynamic Monitor LiDCOrapid v2 Hemodynamic Monitor LiDCOplus Hemodynamic Monitor LiDCOunity v1 Monitor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2017-06-06
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2017-06-06
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2017-06-06
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2007-10-31
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2013-03-21
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2013-03-21
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	1999-01-21
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2016-03-21
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2016-03-21

Official Correspondent

Ji Hee KO

US Agent Details

Mathew Jimenez Business: Masimo Corporation Email: mjimenez@masimo.com Phone: (949) 8128280

Related Public Records

Same Entity

LIDCO LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
K200521	Health & Life Co., Ltd.	Full Automatic(NIBP) Blood Pressure Monitor	2020-06-12
K152003	Andon Health Co, Ltd.	iHealth BP3L Wireless Blood Pressure Monitor	2015-09-24
K952827	Sein Electronics Co., Ltd.	FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000	1996-11-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0001-2008	Bio-Logic Systems Corp	2	Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.

Similar Registrations

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3009156722	SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.	Shenzhen Guangdong, CN
9610816	Philips Medizin Systeme Boeblingen GmbH	BOEBLINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617127. Last updated year: 2026. Please use registration number 9617127 when referencing this establishment in official correspondence.