Medical device licence · 84121 · Class 2
AF531 EE FULL FACE MASK
Yes: licensed in Canada
Licence status Issued (active); first licensed October 8, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 84121
- Licence holder
- Respironics Inc.Murrysville, PA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- October 8, 2010
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AF531 EE LEAK 2 4PT HDG, SU
- AF531 EE LEAK 2 W/ CAPSTRAP, SU
- AF531 EE LEAK 4PT HDG
- AF531 EE LEAK CAPSTRAP
- AF531 EE LK1 NE 4PT HDG, SU, 10 PACK
- AF531 EE LK1 NE CAP STRAP, CKT,SU,5 PACK
- AF531 EE LK1 NE CAP STRAP, SU,10 PACK
- M AF531 EE LEAK1, CKT, NE CAP STP, SU, 5 PCK
- S AF531 EE LEAK1, CKT, NE CAP STP, SU, 5 PCK
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.