Medical device licence · 95074 · Class 2
PC SPIROMETRY SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed April 28, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95074
- Licence holder
- Schiller AgBaar, ZG, Switzerland
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- April 28, 2015
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CALIBRATION ADAPTER
- DISPOSABLE PLASTIC MOUTH PIECES
- PC SPIROMETRY SOFTWARE
- REPLACEMENT FILTER
- SPIRO SENSOR SET
- SPIROVIT PNEUMOTACHO SENSOR
- SPIROVIT PNEUMOTACHO SENSOR USB
- USB SPIRO SENSOR SET
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.