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Spacelabs, Inc.

FDA 510(k) & PMA Approved Devices — 46 products

Total Devices46
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K954962 SPACELABS MEDICAL MULTIGAS ANALYZERCBR1996-05-31 View
510(k) K951605 SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEMDSH1995-07-14 View
510(k) K950779 HEART RATE VARIABILITY SOFTWARE OPTIONDPS1995-04-25 View
510(k) K941165 COMET CAPNOGRAPH MODULECCK1994-10-06 View
510(k) K923788 SPACE LABS MODEL 90560LOS1993-12-06 View
510(k) K912742 ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBEFLL1992-04-20 View
510(k) K913038 SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATIONDSH1991-10-04 View
510(k) K905065 DEFIBRILLATOR LEAD ADAPTERLDD1991-04-12 View
510(k) K910029 PATIENT CARE MANAGEMENT SYSTEM MODIFICATIONDXK1991-01-31 View
510(k) K896903 FIRST MEDIC MODEL 510LDD1990-12-27 View
510(k) K904318 LOCAL REPORT GENERATORDXN1990-12-18 View
510(k) K903702 MODEL 90421 FLEXPORT INTERFACEDQA1990-10-19 View
510(k) K901209 MODEL 90489 PULSE OXIMETER MODULEDQA1990-04-30 View
510(k) K896942 SPACELABS MODEL 90480 EEG MODULEGWQ1990-03-08 View
510(k) K896427 SPACELABS' MODEL 90514, MULTIGAS ANALYZERCCL1990-01-24 View
510(k) K894093 SPACELABS MODEL 90900LOS1989-11-30 View
510(k) K893867 CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULEDQA1989-09-13 View
510(k) K864279 SPACELABS MODEL 90419 PULSE OXIMETER MODULEDQA1987-03-11 View
510(k) K864506 SPACELABS - ARRHYTHMIA NET (TM) LEVEL 1DSI1986-11-25 View
510(k) K864505 SPACELABS ARRHYTHMIA NET (TM) LEVEL 2DSI1986-11-24 View
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