Medical device licence · 104152 · Class 2
O2-MAX CONTROL UNITS
Yes: licensed in Canada
Licence status Issued (active); first licensed January 13, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104152
- Licence holder
- PulmodyneIndianapolis, IN, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- January 13, 2020
- Devices covered
- 2
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- O2-MAX STAND ALONE VARIABLE CONTROL
- O2-MAX TRIO CONTROL UNIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.