Medical Device Manufacturer · US , Hamden , CT

Spacelabs Medical, Inc.

35 submissions · 34 cleared · Since 1993
35
Total
34
Cleared
0
Denied

Spacelabs Medical, Inc. — FDA 510(k) Submissions

Spacelabs Medical, Inc. has submitted 35 FDA 510(k) premarket notifications since 1993, of which 34 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Detector And Alarm, Arrhythmia, Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms), System, Network And Communication, Physiological Monitors, Computer, Diagnostic, Programmable, Display, Cathode-ray Tube, Medical . Use the specialty filter in the sidebar to narrow results.

35 devices
1–12 of 35
SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390
K120616 · MHX Monitor, Physiological,... · Cardiovascular
Mar 2012 29d
SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)
K112962 · MHX Monitor, Physiological,... · Cardiovascular
Nov 2011 28d
SPACELABS MEDICAL PATIENT MONITORS
K102422 · MHX Monitor, Physiological,... · Cardiovascular
Dec 2010 104d
ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION
K093501 · MHX Monitor, Physiological,... · Cardiovascular
Nov 2009 12d
MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220
K082045 · MHX Monitor, Physiological,... · Cardiovascular
Aug 2008 14d
SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810
K063490 · DQK Computer, Diagnostic,... · Cardiovascular
Mar 2007 118d
MCARE 300 VITAL SIGNS MONITOR, MODEL 91220
K062095 · MHX Monitor, Physiological,... · Cardiovascular
Sep 2006 67d
SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847
K062278 · MSX System, Network And... · Cardiovascular
Sep 2006 43d
SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842
K060900 · OLW Index-generating... · Neurology
Jun 2006 81d
SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES
K053599 · CBR Analyzer, Gas,... · Anesthesiology
Apr 2006 117d
SPACELABS MEDICAL MULTIPARAMETER MODULE 91496
K050605 · DSI Detector And Alarm,... · Cardiovascular
May 2005 54d
SPACELABS MEDICAL MULTIPARAMETER MODULE 91496
K050175 · DSI Detector And Alarm,... · Cardiovascular
Mar 2005 37d
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