Medical device licence · 104867 · Class 2
CO-PILOT WIRELESS HANDHELD MULTI-PARAMETER SYSTEM (MODEL H500)
Yes: licensed in Canada
Licence status Issued (active); first licensed July 6, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104867
- Licence holder
- Nonin Medical Inc.Plymouth, MN, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 6, 2020
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CARRYING CASE
- CO-PILOT WIRELESS OXIMETRY SYSTEM
- H500 SYSTEM DISPLAY
- POWER SUPPLY
- REUSABLE FINGER CLIP SENSOR
- SIGNAL PROCESSOR FOR USE WITH H500 SYSTEM
- SIGNAL PROCESSOR SENSOR LOCK, 2-PACK
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.