Medical Device Manufacturer · US , Mchenry , IL

Siemens Elema AB - FDA 510(k) Cleared Devices

63 submissions · 60 cleared · Since 1978

Recent clearances: COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E, KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E, SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E

63

Total

60

Cleared

0

Denied

FDA 510(k) Regulatory Record - Siemens Elema AB Anesthesiology ✕

34 devices

1-12 of 34

Cleared Sep 05, 2003

COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E

Anesthesiology · 333d

Cleared Dec 18, 2001

SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E

Anesthesiology · 266d

Cleared May 26, 2000

MODIFICATION TO KION ANESTHESIA SYSTEM

Anesthesiology · 30d

Cleared Oct 14, 1997

SERVO VENTILATOR 300A

Anesthesiology · 221d

Cleared Oct 25, 1996

SERVO VENTILATOR 300 COMPUTER INTERFACE

Anesthesiology · 297d

Cleared Oct 25, 1996

SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990

Anesthesiology · 283d

Cleared Sep 03, 1987

SIEMENS O2-AIR MIXER 965

Anesthesiology · 80d

Cleared Jul 21, 1987

SERVO VENTILATOR 900 C/D

Anesthesiology · 106d

Cleared Jun 15, 1987

SIEMENS DRY AIR COMPRESSOR

Anesthesiology · 35d

Cleared May 08, 1987

SERVO NEBULIZER 945 SIEMENS-ELEMA AB

Anesthesiology · 38d

Cleared Nov 07, 1986

LUNG MECHANICS SOFTWARE PROGRAM

Anesthesiology · 17d

Cleared Nov 03, 1986

CALIBRATION GAS FOR SERVO GAS MONITOR 120

Anesthesiology · 45d