Medical device licence · 94897 · Class 2
PATIENT SPIROMETRY SETS
Yes: licensed in Canada
Licence status Issued (active); first licensed April 7, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 94897
- Licence holder
- Intersurgical Ltd.East Syracuse, NY, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- April 7, 2015
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADULT SPIROMETRY KIT FOR GE ANAESTHESIA MACHINES
- ADULT SPIROMETRY KIT FOR PHILIPS ANAESTHESIA MACHINES
- ADULT SPIROMETRY SENSOR FOR GE ANAESTHESIA SYSTEMS
- PAEDIATRIC SPIROMETRY KIT FOR GE ANAESTHESIA MACHINES
- PAEDIATRIC SPIROMETRY KIT FOR PHILIPS ANAESTHESIA MACHINES
- PAEDIATRIC SPIROMETRY SENSOR FOR GE ANAESTHESIA SYSTEMS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.