Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611295

FEI Number

3002807992

Entity Name

SPACELABS HEALTHCARE LTD.

City/State/Country

HERTFORD Hertfordshire, GB

Establishment Address

Unit B, Foxholes Centre, JOHN TATE ROAD, HERTFORD Hertfordshire SG13 7DT, GB

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

SPACELABS HEALTHCARE, INC. (Owner Number: 2022906)

Owner / Operator Contact Address

35301 SE CENTER STREET, --, Snoqualmie, WA 98065, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K001727

PMA Number

N/A

All Registered Proprietary Names

Blease Focus Model 90217A Model 90207 Eclipse PRO Eclipse PRO cable P/N 700-0372-00 700-0373-00 700-3878-00 700-0374-00 700-0375-00 700-0376-00 700-0379-00 700-0377-00 Eclipse PRO cable P/N 700-0372-01 700-0373-01 700-3878-01 700-0374-01 700-0375-01 700-0376-01 700-0379-01 700-0377-01 015-0724-00 Micro-V Alternans Sensor (MV4), Case of 5 pouches 040-1747-00 PC, Configured, HearTwave II, 90200 700-0336-01 Patient Cable, Standard Stress, PM-3, US 015-0722-00 Micro-V Alternans Sensor (MV4), Case of 20 pouches 700-0332-01 Micro-V Cable US 700-0338-01 Patient Cable, Standard Stress, PM-3, EU 700-0334-01 Micro-V Cable EU 015-0721-00 Micro-V Alternans Sensor (MV4), Pouch of 7 685-0260-00 PM-3 Patient Module 700-0356-01 EP Junction Cable US 015-0725-00 Micro-V Alternans Sensor (MV4), Case of 1 pouch Eclipse Mini ECG Sensor Eclipse Pro ECG Sensor CardioDirect airway flow sensors Arkon SL3, SL6, and SL12 98900 Eclipse Mini and Assoc. Supplies & Accessories Eclipse MINI patient cables and leadwires Holter Kits Lifecard CF (LCF) EVO Recorder LCF3LCH, LCF3LGER, LCF3LUK, LCFKIT, LCF4L 50-0018, 50-0034, 50-0035, 50-0044, 50-0045, 50-0169 LC12, LC12CH, LC12GER, LC12KIT, LC12KITUS, LC12US Model 90227 OnTrak Ambulatory Blood Pressure Cuffs Cuff Covers Datum Pathfinder SL Holter Analyzer BleaseGenius

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2008-08-01
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2011-10-19
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	Class 2	870.2800	2021-12-01
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2016-10-25
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2020-07-06
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2007-12-17
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2012-04-10
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2012-04-10
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2013-08-19
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	Class 2	870.2800	2022-12-14
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	Class 2	870.2800	2003-08-21
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2014-10-03
CAD	Vaporizer, Anesthesia, Non-Heated	Anesthesiology	Class 2	868.5880	2007-12-18
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2012-05-04
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2012-05-04
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2010-02-11

Official Correspondent

No official correspondent registered.

US Agent Details

Thomas Faris Email: thomas.faris@spacelabs.com Phone: (907) 9536921

Related Public Records

Same Entity

SPACELABS HEALTHCARE, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010157426	Spacelabs Healthcare Inc.	Snoqualmie, WA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K252746	Drägerwerk AG Co. Kgaa	Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)	2026-05-21
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2011	GE Healthcare, LLC	2	GE Datex-Ohmeda Aisys Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland
Z-0008-2014	Draeger Medical, Inc.	2	Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and ventilation to patients during surgical procedures.
Z-0009-2011	GE Healthcare, LLC	2	GE Datex-Ohmeda Avance Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland
Z-0009-2014	GE Healthcare, LLC	2	GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.
Z-0010-2011	GE Healthcare, LLC	2	GE Datex-Ohmeda Amingo Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland

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2112667	Datex-Ohmeda, Inc.	MADISON, WI, US
3003589956	Flextronics Manufacturing (Singapore) Pte Ltd	SINGAPORE South East, SG
3005803793	THORNHILL RESEARCH INC.	TORONTO Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611295. Last updated year: 2026. Please use registration number 9611295 when referencing this establishment in official correspondence.