Medical device licence · 92647 · Class 2
AF421 FULL FACE MASK
Yes: licensed in Canada
Licence status Issued (active); first licensed January 21, 2014. It is in Health Canada’s list of active licences.
- Licence number
- 92647
- Licence holder
- Respironics Inc.Murrysville, PA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- January 21, 2014
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AF421 EE LEAK
- AF421 EE LEAK 2 GLOBAL
- AF421 SE GLOBAL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.