Medical device licence · 88836 · Class 2
AMARA FULL FACE MASK
Yes: licensed in Canada
Licence status Issued (active); first licensed May 11, 2012. It is in Health Canada’s list of active licences.
- Licence number
- 88836
- Licence holder
- Respironics Inc.Murrysville, PA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- May 11, 2012
- Devices covered
- 34
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AMARA DUOPACK W/HGR DOM
- AMARA DUOPACK W/RS FRAME AND RS HGR DOM
- AMARA FITPACK
- AMARA GEL FITPACK
- AMARA LAB MASK W/HGR DOM
- AMARA LAB MASK W/RS FRAME AND RS HGR DOM
- AMARA MASK SE W/HGR INT
- AMARA MASK W/HGR DOM
- AMARA MASK W/HGR INT
- AMARA MASK W/O HGR DOM
- AMARA MASK W/RS FRAME AND RS HGR DOM
- AMARA MASK W/RS FRAME W/O HGR DOM
- L AMARA GEL LAB MASK
- L AMARA GEL MASK
- L AMARA GEL MASK SE W/RS FRAME AND HG INT
- L AMARA GEL MASK W/RS FRAME AND HGR DOM
- L AMARA GEL MASK W/RS FRAME AND HGR INT
- L AMARA GEL MASK W/RS FRAME W/O GHR DOM
- L AMARA MASK W/RS FRAME AND HGR DOM
- L AMARA MASK W/RS FRAME AND HGR INT
- L AMARA MASK W/RS FRAME W/O HGR DOM
- L AMARA MASKSE W/RS FRAME AND HG INT
- L AMARA STARTER KIT
- M AMARA GEL LAB MASK
- M AMARA GEL MASK
- M AMARA MASK SE W/ RS FRAME AND HGR INT
- M AMARA MASK W/ RS FRAME AND HGR INT
- M AMARA STARTER KIT
- P AMARA GEL LAB MASK
- P AMARA GEL MASK
- P AMARA STARTER KIT
- S AMARA GEL LAB MASK
- S AMARA GEL MASK
- S AMARA STARTER KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.