Medical device licence · 90650 · Class 2
ST80I STRESS TEST SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed February 5, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 90650
- Licence holder
- Philips Medizin Systeme Boblingen GmbhBoblingen, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- February 5, 2013
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 12-LEAD LEADSET
- LONG 12-LEAD LEADSET
- ST80I ADVANCED INTERFACE MODULE
- ST80I PRINTER
- ST80I STRESS TEST SYSTEM
- ST80I WIRELESS PATIENT INTERFACE MODULE
- TROLLEY WITH ISOLATION TRANSFORMER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.