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Siemens Elema AB

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
63
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K023354COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81ESeptember 5, 2003
K010923KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392EJanuary 23, 2002
K010925SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407EDecember 18, 2001
K002137CATHCOR DESKTOPOctober 5, 2000
K001315MODIFICATION TO KION ANESTHESIA SYSTEMMay 26, 2000
K970839SERVO VENTILATOR 300AOctober 14, 1997
K960010SERVO VENTILATOR 300 COMPUTER INTERFACEOctober 25, 1996
K960168SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990October 25, 1996
K872278SIEMENS O2-AIR MIXER 965September 3, 1987
K871354SERVO VENTILATOR 900 C/DJuly 21, 1987
K871829SIEMENS DRY AIR COMPRESSORJune 15, 1987
K871366SIEMENS MAIN FLOW BACTERIA FILTERMay 14, 1987
K871293SERVO NEBULIZER 945 SIEMENS-ELEMA ABMay 8, 1987
K864105LUNG MECHANICS SOFTWARE PROGRAMNovember 7, 1986
K863675CALIBRATION GAS FOR SERVO GAS MONITOR 120November 3, 1986
K861707MASTER PROGRAM FLOW & PRESSURE CO2 & LUNG MONITORJune 19, 1986
K861625SERVO GAS MONITOR 120May 2, 1986
K854036MANUAL VENTILATION ACCESSORYOctober 23, 1985
K852771PC INTERFACEOctober 10, 1985
K852772GAS EVACUATION ACCESSORYOctober 10, 1985