Medical device licence · 80462 · Class 2
FULLLIFE MASK
Yes: licensed in Canada
Licence status Issued (active); first licensed August 13, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 80462
- Licence holder
- Respironics Inc.Murrysville, PA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- August 13, 2009
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FULLLIFE DUOPACK W/HEADGEAR
- FULLLIFE FITPACK W/HEADGEAR
- FULLLIFE LAUNCH KIT W/HEADGEAR
- FULLLIFE MASK SE WITH HEADGEAR
- FULLLIFE MASK W/HEADGEAR
- FULLLIFE MASK W/O HEADGEAR
- MW FULLLIFE MASK SE W/HEADGEAR, INTL
- MW FULLLIFE MASK TBE KIT W/HEADGEAR, DOM
- MW FULLLIFE MASK W/HEADGEAR, DOMESTIC
- MW FULLLIFE MASK W/HEADGEAR, INTL
- MW FULLLIFE MASK W/O HEADGEAR, DOMESTIC
- MW/MW FULLLIFE DUOPACK W/HEADGEAR, DOMESTIC
- MW/MW FULLLIFE DUOPACK W/HEADGEAR, INTL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.