Medical device licence · 89112 · Class 2
HEART SYNC DEFIBRILLATION ELECTRODES
Yes: licensed in Canada
Licence status Issued (active); first licensed June 25, 2012. It is in Health Canada’s list of active licences.
- Licence number
- 89112
- Licence holder
- Graphic Controls Acquisition Corp. D.B.A. Nissha Medical TechnologiesBuffalo, NY, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- June 25, 2012
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADULT RADIOLUCENT ECG/DEFIB/PACING ELECTRODE
- ADULT RADIOTRANSPARENT ECG/DEFIB/PACING ELECTRODE
- PEDIATRIC RADIOLUCENT ECG/DEFIB/PACING ELECTRODE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.