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Spacelabs Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
35
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K120616SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390March 29, 2012
K112962SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)November 2, 2011
K102422SPACELABS MEDICAL PATIENT MONITORSDecember 7, 2010
K093501ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATIONNovember 24, 2009
K082045MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220August 1, 2008
K063490SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810March 15, 2007
K062095MCARE 300 VITAL SIGNS MONITOR, MODEL 91220September 29, 2006
K062278SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847September 19, 2006
K060900SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842June 23, 2006
K053599SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIESApril 19, 2006
K050605SPACELABS MEDICAL MULTIPARAMETER MODULE 91496May 3, 2005
K050175SPACELABS MEDICAL MULTIPARAMETER MODULE 91496March 4, 2005
K013046COSMOS SYSTEMAugust 21, 2002
K021097QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52June 28, 2002
K003663SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODEJune 28, 2001
K992749ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841January 14, 2000
K981655SPACELABS MEDICAL DISPOSABLE SP02 SENSORDecember 3, 1999
K983996SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEMJune 3, 1999
K981530SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEMNovember 20, 1998
K972502SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496May 28, 1998