Medical device licence · 80910 · Class 3
SPECTRO2/20 PULSE OXIMETER
Yes: licensed in Canada
Licence status Issued (active); first licensed October 15, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 80910
- Licence holder
- Icu Medical Inc.Dublin, OH, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 15, 2009
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DOCKING STATION/PRINTER SYSTEM
- SPECTRO2/20 PULSE OXIMETER SYSTEM
- SPECTRO2/20 PULSE OXIMETER SYSTEM - SENSOR
- SPECTRO2/20 SYSTEM - DOCKING STATION
- SPECTRO2/20 SYSTEM - PRINTER
- SPECTRO2/20 SYSTEM - PULSE OXIMETER
- SPECTRO2/20 SYSTEM - RECHARGEABLE LI-ION BATTERY PACK
- SPECTRO2/20 SYSTEM - USB INTERFACE CABLE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.