Medical device licence · 103780 · Class 2
CADWELL ZENITH SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 25, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 103780
- Licence holder
- Cadwell Industries, Inc.Kennewick, WA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 25, 2019
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 12-INPUT TOUCHPROOF ADAPTER
- 16-INPUT TOUCHPROOF ADAPTER
- 8-INPUT TOUCHPROOF ADAPTER
- ARC PHOTIC STIMULATOR
- ARC SOFTWARE
- CADWELL PATIENT EVENT SWITCH
- CASCADE IOMAX BASE MODULE
- CASCADE IOMAX CORTICAL MODULE
- Q-VIDEO MOBILE 3 RECORDER
- SIERRA SUMMIT FOOTSWITCH
- ZENITH 144-CHANNEL AMPLIFIER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.