Medical device licence · 91541 · Class 2
ESPION E3 ELECTROPHYSIOLOGY SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 26, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 91541
- Licence holder
- Diagnosys LlcLowell, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- June 26, 2013
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ATTACHE (FOR E3)
- COLORBURST HANDHELD STIMULATOR (CB) (FOR E3)
- COLORDOME DESK TOP GANZFELD STIMULATOR (CD) (FOR E3)
- COLORDOME DESK TOP POWER SUPPLY (FOR E3)
- COLORDOME GANZFELD (CD) - ESPION PROFILE RED (FOR E3)
- COLORFLASH-HANDHELD FLASH STIMULATOR
- E3 ESPION CONSOLE
- ENVOY
- ESPION PROFILE GOLD (FOR E3)
- MULTI FOCAL/PATTERN (MF) STIMULATOR (FOR E3)
- PATTERN STIMULATOR (PSG) (FOR E3)
- PROFILE FULL-FIELD/MULTIFOCAL ERG (FOR E3)
- STAND ALONE CONTROLLER (FOR E3)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.