Medical device licence · 63122 · Class 2
BIO-TUNER
No longer licensed: cancelled: quality-system requirement (2003)
Licence status Cancelled: quality-system requirement (2003); first licensed October 20, 2003; ended February 16, 2004. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 63122
- Licence holder
- Sota Instruments Inc.Penticton, BC, Canada
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 20, 2003
- Ended
- February 16, 2004
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BIO-TUNER HEADSET ELECTRODES
- BIO-TUNER TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.