SPACELABS HEALTHCARE LTD.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
9611295	3002807992	SPACELABS HEALTHCARE LTD.	1	N	2026-01-01	Unit B, Foxholes Centre JOHN TATE ROAD HERTFORD Hertfordshire GB SG13 7DT

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
4856	1431397863	K972649	CARDIOCALL CARDIAC EVENT RECORDER	DXH	1997-12-04
4856	1429225064	K942799	DATUM	CAD	1995-04-13
4856	1481888941	K212317	Eclipse MINI Model 98900	MWJ	2022-11-07
4856	1798568859	K211651	Eclipse PRO	MWJ	2021-11-22
4856	1082283953	K201921	Spacelabs Lifescreen PRO Analyzer	DQK	2021-03-26
4856	1582606807	K152881	SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM	DQK	2016-04-01
4856	1335950214	K141113	SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE	DXN	2014-09-26
4856	1361965076	K130207	SPACELABS HEALTHCARE CARDIOEXPRESS	DPS	2013-07-23
4856	1858115070	K113051	SPACELABS ARKON ANESTHESIA WORKSTATION	CBK	2012-03-22
4856	1567875169	K112729	BLEASE700/900 SERIES VENTILATORS	CBK	2012-06-11
4856	1824020965	K110001	SPACELABS PATHFINDER SL HOLTER ANALYZER	DQK	2011-06-14
4856	1821308398	K103732	SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR	DXN	2011-02-04
4856	1379318683	K101850	SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION	CBK	2011-03-02
4856	1017921862	K050225	HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM	DQK	2005-04-07
4856	1586173001	K024283	CARDIODIRECT, MODELS 12M, 12I, 12S	DPS	2003-08-01
4856	1982007721	K011837	LIFECARD CF 7 DAY	MWJ	2001-07-13
4856	1414036335	K003251	BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690	BSZ	2001-05-23
4856	1288308778	K001727	MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES	BSZ	2000-08-09
4856	1950217327

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
DQK	4	2021-03-26
MWJ	3	2022-11-07
CBK	3	2012-06-11
DXN	2	2014-09-26
DPS	2	2013-07-23
BSZ	2	2001-05-23
DXH	1	1997-12-04
CAD	1	1995-04-13