Medical device licence · 22538 · Class 2
SLEEP DIAGNOSTIC SYSTEMS
No longer licensed: suspended: invalid quality-system certificate
Licence status Suspended: invalid quality-system certificate; first licensed July 28, 2000; ended November 30, 2020. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 22538
- Licence holder
- Vyaire Medical FormerlyYorba Linda, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- July 28, 2000
- Ended
- November 30, 2020
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACQUISITION STATION
- ACQUISITION/REPORT CENTER
- BICORE II
- RESPITRACE QDC
- SOMNOSTAR
- SOMNOSTAR PT
- SOMNOTRAC OMEGA
- T3 PORTABLE SLEEP DIAGNOSTIC SYSTEM
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.