Medical device licence · 98601 · Class 3
MAXO2ME
Yes: licensed in Canada
Licence status Issued (active); first licensed February 14, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 98601
- Licence holder
- Maxtec, LlcSalt Lake City, UT, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 14, 2017
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MAX-550E EXTERNAL MEDICAL OXYGEN SENSOR
- MAXBLEND2/MAXO2ME POWER SUPPLY
- MAXO2 ME+P OXYGEN AND PRESSURE MONITOR
- MAXO2ME INTERNATIONAL MONITOR
- MAXO2ME SENSOR CABLE
- POWER SUPPLY
- PRESSURE MONITORING LINE WITH MOISTURE CONTROL TUBING
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.