Spacelabs Healthcare, Ltd. - FDA 510(k) Cleared Devices
9
Total
9
Cleared
0
Denied
FDA 510(k) cleared devices by Spacelabs Healthcare, Ltd. Cardiovascular ✕
8 devices
Cleared
Nov 07, 2022
Eclipse MINI Model 98900
Cardiovascular
469d
Cleared
Nov 22, 2021
Eclipse PRO
Cardiovascular
178d
Cleared
Mar 26, 2021
Spacelabs Lifescreen PRO Analyzer
Cardiovascular
259d
Cleared
Apr 01, 2016
SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM
Cardiovascular
184d
Cleared
Sep 26, 2014
SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE
Cardiovascular
149d
Cleared
Jul 23, 2013
SPACELABS HEALTHCARE CARDIOEXPRESS
Cardiovascular
176d
Cleared
Jun 14, 2011
SPACELABS PATHFINDER SL HOLTER ANALYZER
Cardiovascular
162d
Cleared
Feb 04, 2011
SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR
Cardiovascular
44d