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Spacelabs Medical, Inc.

FDA 510(k) & PMA Approved Devices — 35 products

Total Devices35
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K120616 SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390MHX2012-03-29 View
510(k) K112962 SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)MHX2011-11-02 View
510(k) K102422 SPACELABS MEDICAL PATIENT MONITORSMHX2010-12-07 View
510(k) K093501 ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATIONMHX2009-11-24 View
510(k) K082045 MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220MHX2008-08-01 View
510(k) K063490 SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810DQK2007-03-15 View
510(k) K062095 MCARE 300 VITAL SIGNS MONITOR, MODEL 91220MHX2006-09-29 View
510(k) K062278 SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847MSX2006-09-19 View
510(k) K060900 SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842OLW2006-06-23 View
510(k) K053599 SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIESCBR2006-04-19 View
510(k) K050605 SPACELABS MEDICAL MULTIPARAMETER MODULE 91496DSI2005-05-03 View
510(k) K050175 SPACELABS MEDICAL MULTIPARAMETER MODULE 91496DSI2005-03-04 View
510(k) K013046 COSMOS SYSTEMDSI2002-08-21 View
510(k) K021097 QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52DSI2002-06-28 View
510(k) K003663 SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODEBSZ2001-06-28 View
510(k) K992749 ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841MSX2000-01-14 View
510(k) K981655 SPACELABS MEDICAL DISPOSABLE SP02 SENSORDQA1999-12-03 View
510(k) K983996 SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEMMHX1999-06-03 View
510(k) K981530 SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEMBSZ1998-11-20 View
510(k) K972502 SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496DSI1998-05-28 View
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