Spacelabs Healthcare L T D

FDA Filings

This page includes the latest FDA filings for Spacelabs Healthcare L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number9611295
FEI Number3002807992
NameSPACELABS HEALTHCARE LTD.
Owner & OperatorSPACELABS HEALTHCARE, INC.
Contact Address35301 SE CENTER STREET --
Snoqualmie WA 98065 US
Official Correspondent
  • AL - VAN HOUDT
  • x-425-3635970-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressUnit B, Foxholes Centre JOHN TATE ROAD
HERTFORD Hertfordshire, SG13 7DT GB
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device
Company
DeviceDate
Spacelabs Healthcare Ltd.
Spacelabs Lifescreen PRO Analyzer2021-03-26
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
700-0356-01 EP Junction Cable US2016-10-25
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
700-0338-01 Patient Cable, Standard Stress, PM-3, EU2016-10-25
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
700-0336-01 Patient Cable, Standard Stress, PM-3, US2016-10-25
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
700-0334-01 Micro-V Cable EU2016-10-25
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
700-0332-01 Micro-V Cable US2016-10-25
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
685-0260-00 PM-3 Patient Module2016-10-25
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
040-1747-00 PC, Configured, HearTwave II, 902002016-10-25
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
015-0725-00 Micro-V Alternans Sensor (MV4), Case of 1 pouch2016-10-25
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
015-0724-00 Micro-V Alternans Sensor (MV4), Case of 5 pouches2016-10-25
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
015-0722-00 Micro-V Alternans Sensor (MV4), Case of 20 pouches2016-10-25
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
015-0721-00 Micro-V Alternans Sensor (MV4), Pouch of 72016-10-25
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
Sentinel2016-04-14
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
Sentinel V11.x2016-04-14
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
Sentinel V10.x2016-04-14
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
Model 982012016-04-14
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
Model 982002016-04-14
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
Sentinel2016-04-14
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
Sentinel V11.x2016-04-14
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
Sentinel V10.x2016-04-14
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
Model 982012016-04-14
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
Model 982002016-04-14
SPACELABS HEALTHCARE LTD.
SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM2016-04-01
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
OnTrak2014-10-03
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
Model 902272014-10-03
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
Cuff Covers2014-10-03
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
Ambulatory Blood Pressure Cuffs2014-10-03
SPACELABS HEALTHCARE LTD.
SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE2014-09-26
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
SL3, SL6, and SL122013-08-19
SPACELABS HEALTHCARE LTD.
SPACELABS HEALTHCARE CARDIOEXPRESS2013-07-23
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
Models 950, 970, & 9902012-07-13
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
900 Series Ventilator2012-07-13
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
BleaseSirius2012-07-13
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
Pathfinder SL Holter Analyzer2012-05-04
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
Pathfinder SL Holter Analyzer2012-05-04
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
airway flow sensors2012-04-10
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
Arkon2012-04-10
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
airway flow sensors2012-04-10
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
Arkon2012-04-10
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
Model 90217A2011-10-19
SPACELABS HEALTHCARE LTD.
SPACELABS PATHFINDER SL HOLTER ANALYZER2011-06-14
SPACELABS HEALTHCARE LTD.
SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION2011-03-02
SPACELABS HEALTHCARE LTD.
SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR2011-02-04
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
BleaseGenius2010-02-11
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
Blease Focus2008-08-01
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
Datum2007-12-18
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
CardioDirect2007-12-17
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
patient cables and leadwires2003-08-21
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
Lifecard CF (LCF)2003-08-21
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
LCF3LCH, LCF3LGER, LCF3LUK, LCFKIT, LCF4L2003-08-21
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
LC12, LC12CH, LC12GER, LC12KIT, LC12KITUS, LC12US2003-08-21
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
Holter Kits2003-08-21
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
EVO Recorder2003-08-21
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
50-0018, 50-0034, 50-0035, 50-0044, 50-0045, 50-01692003-08-21
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
Patient cables & leadwires1998-01-08
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
Holter kits1998-01-08
SPACELABS HEALTHCARE LTD. [SPACELABS HEALTHCARE, INC.]
CARDIOCALL EVENT RECORDER1998-01-08

Related Finance Registrations
NCAGE CodeU1A64SPACELABS HEALTHCARE LTD
CAGE CodeU1A64SPACELABS HEALTHCARE LTD
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