Medical device licence · 91535 · Class 2
SIERRA SUMMIT
Yes: licensed in Canada
Licence status Issued (active); first licensed August 20, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 91535
- Licence holder
- Cadwell Industries, Inc.Kennewick, WA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- August 20, 2013
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- REFLEX HAMMER
- SIERRA SUMMIT BONE VIBRATOR
- SIERRA SUMMIT FOOTSWITCH
- SIERRA SUMMIT VEP LED GOGGLES
- SUMMIT AMPLIFIER
- SUMMIT AUDITORY HEADPHONES
- SUMMIT BASE UNIT
- SUMMIT ELECTRICAL STIMULATOR
- SUMMIT REMOTE INPUT BOX
- SUMMIT SOFTWARE
- SURFACE TEMPERATURE PROBE
- VEP CALIBRATION SENSOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.