Medical device licence · 35150 · Class 2
OSCAR 2 ABPM SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 2, 2002. It is in Health Canada’s list of active licences.
- Licence number
- 35150
- Licence holder
- Suntech Medical Inc.Morrisville, NC, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- January 2, 2002
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OSCAR 2, ABP MONITOR
- OSCAR 2, ABP SYSTEM
- OSCAR 2, ABP/CBP MONITOR
- OSCAR 2, ABP/CBP SYSTEM
- OSCAR II OSCILLOMETRIC AMBULATORY BLOOD PRESSURE MONITOR
- USB CABLE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.