Medical Device Manufacturer · US , Tewksbury , MA

Datex-Ohmeda - FDA 510(k) Cleared Devices

41 submissions · 41 cleared · Since 2000

Recent clearances: Novii+ Wireless Patch System

41

Total

41

Cleared

0

Denied

FDA 510(k) Regulatory Record - Datex-Ohmeda Neurology ✕

2 devices

1-2 of 2

Cleared Jan 13, 2003

DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES

Neurology · 90d

Cleared Jan 10, 2002

DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES

Neurology · 90d