Medical device licence · 78475 · Class 3
DTU-215B EPSTIM SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed November 20, 2008; ended December 9, 2025. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 78475
- Licence holder
- Fischer MedicalDenver, CO, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- November 20, 2008
- Ended
- December 9, 2025
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- EPSTIM SYSTEM - CATHETER CONNECTION BOX (CCB)
- EPSTIM SYSTEM - CONTROLLER
- EPSTIM SYSTEM - DTU-215B CARDIAC STIMULATOR
- EPSTIM SYSTEM - REMOTE STIMULUS ISOLATION UNIT (RSIU)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.