Spacelabs Healthcare is one of 18333 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Spacelabs Healthcare - FDA 510(k) Cleared Devices
Recent clearances: elance Vital Signs Monitor, Central Monitor Software, SPACELABS HEALTHCARE TELEMETRY RECEIVER, XHIBIT CENTRAL STATION, MODEL 96102
10
Total
10
Cleared
0
Denied
Spacelabs Healthcare has 10 FDA 510(k) cleared medical devices. Based in Nederland, US.
Historical record: 10 cleared submissions from 2011 to 2015. Primary specialty: Anesthesiology.
Browse the FDA 510(k) cleared devices submitted by Spacelabs Healthcare Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Speed TO Market, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Spacelabs Healthcare
10 devices
Cleared
Nov 05, 2015
elance Vital Signs Monitor, Central Monitor Software
Cardiovascular
268d
Cleared
Sep 09, 2014
SPACELABS HEALTHCARE TELEMETRY RECEIVER
Cardiovascular
127d
Cleared
Apr 22, 2013
XHIBIT CENTRAL STATION, MODEL 96102
Cardiovascular
277d
Cleared
Mar 21, 2013
CAPNO MODULE, 92517
Anesthesiology
64d
Cleared
Jul 13, 2012
CAPNOGRAPHY PAD (92516)
Anesthesiology
100d
Cleared
Jun 11, 2012
BLEASE700/900 SERIES VENTILATORS
Anesthesiology
265d
Cleared
Jun 06, 2012
ARIATELE TELEMETRY TRANSMITTER (96281)
Cardiovascular
19d
Cleared
Mar 22, 2012
SPACELABS ARKON ANESTHESIA WORKSTATION
Anesthesiology
161d
Cleared
Oct 05, 2011
SPEACELABS MULTIGAS MODULE
Anesthesiology
69d
Cleared
Apr 19, 2011
SPACELABS SMART DISCLOSURE SYSTEM
Cardiovascular
29d