Medical device licence · 76514 · Class 2
FACE MASKS
Yes: licensed in Canada
Licence status Issued (active); first licensed March 5, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 76514
- Licence holder
- Respironics Inc.Murrysville, PA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- March 5, 2008
- Devices covered
- 19
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FITLIFE LAB MASK DOM
- FITLIFE MASK EE W/HEADGEAR, INTERNATIONAL
- FITLIFE MASK SE WITH HEAD GEAR INTERNATIONAL
- FITLIFE MASK W/HGR DOM
- FITLIFE MASK W/HGR INT
- FITLIFE MASK W/O HEADGEAR
- FITLIFE MASK W/O HGR DOM
- FITLIFE WITH LAB HEAD GEAR LAB MASK DOM
- PERFORMAX MPU DOM W/EE LEAK 2
- PERFORMAX MPU INTL W/EE LEAK 2,+ 4 HG
- PERFORMAX MPU INTL W/SE,+ 4 HG
- PERFORMAX MPU W/EE LEAK 2 & SE
- PERFORMAX MPU W/EE LEAK 2 & SE,+ 4 HG
- PERFORMAX SINGLE PATIENT USE FACE MASK
- PERFORMAX SPU MASK WITH EE
- PERFORMAX SPU MASK WITH SE
- PERFORMAX SU W/EE LEAK 2
- PERFORMAX SU W/SE
- PERFORMAX TOTAL FACE MASK
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.