FDA.reportPublic FDA data

SPACELABS HEALTHCARE LTD.

Matched from indexed company URL: Spacelabs Healthcare Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96112953002807992SPACELABS HEALTHCARE LTD.1N2026-01-01Unit B, Foxholes Centre JOHN TATE ROAD HERTFORD Hertfordshire GB SG13 7DT
30101574263010157426Spacelabs Healthcare Inc.1Y2026-01-0135301 SE Center St Snoqualmie WA US 98065

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1551181740271787K983996SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEMMHX1999-06-03
48561431397863K972649CARDIOCALL CARDIAC EVENT RECORDERDXH1997-12-04
1551181681382580K954282ULTRACUFF BLOOD PRESSURE CUFF AND INFLATION BAGDXQ1996-02-06
48561429225064K942799DATUMCAD1995-04-13
1551181576953538K941165COMET CAPNOGRAPH MODULECCK1994-10-06
1551181817219118K940214STATCORP INC. DISPOSABLE BLOOD PRESSURE CUFFDXQ1994-02-22
1551181589560866K932842SPACELABS MEDICAL MODEL 90481 EEG MODULEGWQ1994-03-02
1551181105072757K925510MODEL 90478 & 90479 TELEMETRY REC. MODULE&HOUSINGDSI1994-10-27
1551181287505892K903702MODEL 90421 FLEXPORT INTERFACEDQA1990-10-19
1551181795550211K893867CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULEDQA1989-09-13
1551181070112047K842616SPACELABS ALPHA PC PATIENT COMPUTERDSI1984-10-18
48561481888941K212317Eclipse MINI Model 98900MWJ2022-11-07
1551181481888941K212317Eclipse MINI Model 98900MWJ2022-11-07
48561798568859K211651Eclipse PROMWJ2021-11-22
48561082283953K201921Spacelabs Lifescreen PRO AnalyzerDQK2021-03-26
1551181845628290K193421Smart Alarm InterfaceMSX2020-10-30
1551181068572157K183370PeraMobile and PeraWatchMWI2019-09-11
1551181810150848K172959PeraServer and PeraTrendMWI2018-05-01
48561582606807K152881SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEMDQK2016-04-01
1551181807729391K152801ULTRACHECK SPACELABS ABP CUFF-CHILD, ULTRACHECK SPACELABS ABP CUFF-SMALL ADULT, ULTRACHECK SPACELABS ABP CUFF-ADULT, ULTRACHECK SPACELABS ABP CUFF-LARGE ADULTDXQ2015-10-27
1551181402236887K150329elance Vital Signs Monitor, Central Monitor SoftwareMHX2015-11-05
1551181278655309K141156SPACELABS HEALTHCARE TELEMETRY RECEIVERMHX2014-09-09
48561335950214K141113SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVEDXN2014-09-26
1551181335950214K141113SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVEDXN2014-09-26
48561361965076K130207SPACELABS HEALTHCARE CARDIOEXPRESSDPS2013-07-23
1551181989885112K130112CAPNO MODULE, 92517CCK2013-03-21
1551181394070328K122365ULTRACHECK CURVE BLOOD PRESSURE CUFFSOED2013-06-04
1551181621979737K122146XHIBIT CENTRAL STATION, MODEL 96102MHX2013-04-22
1551181294398510K121480ARIATELE TELEMETRY TRANSMITTER (96281)MHX2012-06-06
1551181514686555K121017CAPNOGRAPHY PAD (92516)CCK2012-07-13
1551181157692455K120616SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390MHX2012-03-29
48561858115070K113051SPACELABS ARKON ANESTHESIA WORKSTATIONCBK2012-03-22
1551181841774629K112962SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)MHX2011-11-02
48561567875169K112729BLEASE700/900 SERIES VENTILATORSCBK2012-06-11
1551181640677349K112173SPEACELABS MULTIGAS MODULECBR2011-10-05
1551181057816699K110779SPACELABS SMART DISCLOSURE SYSTEMDQK2011-04-19
48561824020965K110001SPACELABS PATHFINDER SL HOLTER ANALYZERDQK2011-06-14
48561821308398K103732SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITORDXN2011-02-04
1551181732995133K103142SPACELABS MULTI-PARAMETER MODULEDSI2011-03-03
1551181251217167K102422SPACELABS MEDICAL PATIENT MONITORSMHX2010-12-07
48561379318683K101850SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATIONCBK2011-03-02
1551181661337565K082045MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220MHX2008-08-01
1551181642644223K071885ANTIMICROBIAL AND SINGLE-PATIENT CUFFSOED2007-12-20
1551182028137977K063490SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810DQK2007-03-15
1551181066824671K062278SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847MSX2006-09-19
1551181539263115K060900SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842OLW2006-06-23
1551181414338949K053599SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIESCBR2006-04-19
48561017921862K050225HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEMDQK2005-04-07
1551181740608874K031124POLARIS 95000-A BEDSIDE/TRANSPORT MONITORMHX2003-12-04
48561586173001K024283CARDIODIRECT, MODELS 12M, 12I, 12SDPS2003-08-01
48561982007721K011837LIFECARD CF 7 DAYMWJ2001-07-13
48561414036335K003251BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690BSZ2001-05-23
48561288308778K001727MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINESBSZ2000-08-09
1551181537282121
1551181082283953
1551181288308778
1551181379318683
1551181414036335
1551181431397863
1551181470248004
1551181567875169
1551181582606807
1551181586173001
1551181798568859
1551181821308398
1551181824020965
1551181858115070
48561950217327
1551181982007721
1551182008751812

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MHX102015-11-05
DQK62021-03-26
MWJ42022-11-07
DXQ32015-10-27
DXN32014-09-26
CCK32013-03-21
CBK32012-06-11
DSI32011-03-03
MSX22020-10-30
MWI22019-09-11
DPS22013-07-23
OED22013-06-04
CBR22011-10-05
BSZ22001-05-23
DQA21990-10-19
OLW12006-06-23
DXH11997-12-04
CAD11995-04-13
GWQ11994-03-02

PMN#

GUDID#

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