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FDA 510(k) Applications Submitted by SPACELABS MEDICAL INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K060900
04/03/2006
SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842
SPACELABS MEDICAL INC.
K053599
12/23/2005
SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES
SPACELABS MEDICAL INC.
K050605
03/10/2005
SPACELABS MEDICAL MULTIPARAMETER MODULE 91496
SPACELABS MEDICAL INC.
K093501
11/12/2009
ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION
SPACELABS MEDICAL INC.
K062095
07/24/2006
MCARE 300 VITAL SIGNS MONITOR, MODEL 91220
SPACELABS MEDICAL INC.
K062278
08/07/2006
SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847
SPACELABS MEDICAL INC.
K102422
08/25/2010
SPACELABS MEDICAL PATIENT MONITORS
SPACELABS MEDICAL INC.
K063490
11/17/2006
SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810
SPACELABS MEDICAL INC.
K112962
10/05/2011
SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)
SPACELABS MEDICAL INC.
K082045
07/18/2008
MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220
SPACELABS MEDICAL INC.
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