Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010157426

FEI Number

3010157426

Entity Name

Spacelabs Healthcare Inc.

City/State/Country

Snoqualmie, WA, US

Establishment Address

35301 SE Center St, Snoqualmie, WA 98065, US

Establishment Type(s)

Manufacture Medical Device

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

K925510

PMA Number

N/A

All Registered Proprietary Names

Model 91810 - Full Disclosure Capnography Module Model 92517 Xhibit Model 96102 XC4 Model 96501 21.5 inch display, P/N 011-0241-02 21.5 inch display, P/N 011-0262-00 Model 91220 Unifusor pressure infusors CardioDirect BISx module Model 91482 EEG Patient Cables and Leadwires EEG Patient Cable Adapters Ultracheck Curve blood pressure cuffs blood pressure hoses blood pressure accessories 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 Sentinel Sentinel V10.x Model 98200 Model 98201 Sentinel V11.x Ultracheck blood pressure cuffs blood pressure accessories blood pressure hoses Model 96181 Smart Alarm Interface Models 90436A-15, 90436A-16, 90437A-05, 90439, 90442A-02, 90442-03 Models 91439A-A, 91439B, 91439B-A, 91443A-A, 91443B-A Models 90436A-01, 90436A-07, 90436A-09, 90436A-10-32, 90436A-10B, 90436A-10E Models 90519B-A, 91436A-A, 91436B-A, 91436C-A, 91436D-A, 91436E-A, 91438A-A Model 90227 OnTrak Ambulatory Blood Pressure Cuffs Cuff Covers Aria-Tele Model 96281 Models 90343, 90347, 91343, 91347 Models 90478 & 90479 Enhanced Telemetry Receiver Model 96280 Blease Focus Models 91881 & 92881 Models 90449, 90469, & 91449 Softcheck blood pressure cuffs blood pressure accessories blood pressure hoses Ultracheck Spacelabs ABP cuffs blood pressure accessories blood pressure hoses Model 92516 Capnography Pod BleaseSirius Pathfinder SL Holter Analyzer ECG electrodes blood pressure cuffs & hoses elance Central Station Monitor Model 93300 patient adapter cables ECG leadwires & cables Model 93900 elance Vital Signs Monitor Models 91847 and 92847 part number 14000018 700 series ventilators blood pressure cuffs and hoses ECG electrodes UltraView SL Command Module Model 90496 Command Module Model 91496 Pulse oximetry cables and sensors ECG leadwires & cables Patient adapter cables Models 91393 and 94267 Single Care Cuffs BleaseGenius Model 92810 - Smart Disclosure CARDIOCALL EVENT RECORDER Patient cables & leadwires Holter kits Peraserver Peratrend 98900 Eclipse Mini and Assoc. Supplies & Accessories Eclipse MINI Models 90341 & 91341

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2009-10-28
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2013-04-05
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2013-06-03
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2013-06-03
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2013-06-03
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2013-06-03
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2009-10-28
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	Class 1	880.5420	2014-10-09
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2007-12-17
OLW	Index-Generating Electroencephalograph Software	Neurology	Class 2	882.1400	2007-12-18
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2007-12-18
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2007-12-18
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2007-12-18
OED	Antimicrobial Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2014-10-09
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	Class 2	870.2800	2021-12-01
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2016-04-14
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2016-04-14
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2014-10-09
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2020-12-07
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2009-10-28
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2014-10-03
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2012-07-13
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2007-12-18
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2014-10-03
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2014-10-03
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2014-10-03
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2014-10-03
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2008-08-01
DSF	Recorder, Paper Chart	Cardiovascular	Class 1	870.2810	1994-12-13
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2014-10-09
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2015-10-30
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2012-08-07
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2012-07-13
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2012-05-04
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2012-05-04
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2019-03-15
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2012-07-13
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2015-03-05
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2012-04-10
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2012-04-10
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2012-04-10
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2012-04-10
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2012-04-10
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2012-04-10
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2011-11-10
OED	Antimicrobial Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2017-06-20
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2010-02-11
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2012-07-13
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	1998-01-08
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2023-09-29
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	Class 2	870.2800	2022-12-14
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2007-12-18

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
9611295	SPACELABS HEALTHCARE LTD.	HERTFORD Hertfordshire, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K935043	Siemens Medical Electronics	SIEMENS CLINICAL WORK STATION	1995-04-07
K170948	Acutus Medical, Inc.	AcQMap High Resolution Imaging and Mapping System	2017-10-16
K242016	ABBOTT MEDICAL	EnSite X EP System	2024-08-09
K172182	St. Jude Medical (Now Part of the Abbott Medical)	QUANTIEN Measurement System	2017-08-18
K252013	ABBOTT MEDICAL	EnSite X EP System	2025-09-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2016	Biosense Webster, Inc.	2	Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Z-0032-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
Z-0033-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.
Z-0034-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641
Z-0035-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658

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3013300026	BIOSENSE WEBSTER, INC.	Irvine, CA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010157426. Last updated year: 2026. Please use registration number 3010157426 when referencing this establishment in official correspondence.