Medical device licence · 100628 · Class 3
RAD-97 PULSE CO-OXIMETER
Yes: licensed in Canada
Licence status Issued (active); first licensed February 27, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 100628
- Licence holder
- Masimo CorporationIrvine, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- February 27, 2018
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- RAD-97 PULSE CO-OXIMETER
- RAD-97 PULSE CO-OXIMETER WITH NOMOLINE CAPNOGRAPHY
- RAD-97 PULSE CO-OXIMETER WITH NONINVASIVE BLOOD PRESSURE
- RAD-97 UPGRADE TOOL, EVE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.