Medical device licence · 80924 · Class 2
FLOW-SAFE DISPOSABLE CPAP SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 16, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 80924
- Licence holder
- Mercury MedicalClearwater, FL, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- October 16, 2009
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FLOW-SAFE CPAP SYSTEM ONLY W/MANOMETER/PRESSURE VALVE/TUBING
- FLOW-SAFE CPAP SYSTEM W/ADULT MASK/MANOMETER/PRESSURE VALVE/HARNESS/TUBING
- FLOW-SAFE CPAP SYSTEM W/CHILD MASK/MANOMETER/PRESSURE VALVE/HARNESS/TUBING
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.