Medical device licence · 79434 · Class 2
HOLTER SYSTEMS
Yes: licensed in Canada
Licence status Issued (active); first licensed April 1, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 79434
- Licence holder
- Global Instrumentation, LlcEast Syracuse, NY, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- April 1, 2009
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PCH100 OFFICE HOLTER SYSTEM
- PCH100 OFFICE HOLTER WITH SOFTWARE KIT
- PCH200 EXPERT HOLTER SYSTEM
- PCH200 EXPERT HOLTER WITH SOFTWARE KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.