Medical device licence · 96564 · Class 2
NIM-ECLIPSE E4 NERVE MONTORING SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed February 18, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 96564
- Licence holder
- Medtronic Xomed Inc.Jacksonville, FL, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- February 18, 2016
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- LED GOGGLES
- NIM-ECLIPSE SYSTEM - AMPLIFIER DIG PREAMPLIFIER
- NIM-ECLIPSE SYSTEM - CONTROLLER
- NIM-ECLIPSE SYSTEM - EXTENDER STIMULATOR
- NIM-ECLIPSE SYSTEM - MODULE, PATIENT
- NIM-ECLIPSE, COMPUTER, DESKTOP, E4
- NIM-ECLIPSE, COMPUTER, NOTEBOOK, E4
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.