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FDA 510(k) Applications Submitted by Spacelabs Healthcare Ltd.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K141113
04/30/2014
SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE
SPACELABS HEALTHCARE LTD.
K152881
09/30/2015
SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM
SPACELABS HEALTHCARE LTD.
K211651
05/28/2021
Eclipse PRO
Spacelabs Healthcare Ltd.
K201921
07/10/2020
Spacelabs Lifescreen PRO Analyzer
Spacelabs Healthcare Ltd.
K212317
07/26/2021
Eclipse MINI Model 98900
Spacelabs Healthcare Ltd.
K110001
01/03/2011
SPACELABS PATHFINDER SL HOLTER ANALYZER
SPACELABS HEALTHCARE LTD.
K130207
01/28/2013
SPACELABS HEALTHCARE CARDIOEXPRESS
SPACELABS HEALTHCARE LTD.
K101850
07/01/2010
SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION
SPACELABS HEALTHCARE LTD.
K103732
12/22/2010
SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR
SPACELABS HEALTHCARE LTD.
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