Medical device licence · 79435 · Class 2
HOLTER SOFTWARE
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
- 79435
- Licence holder
- Global Instrumentation, LlcEast Syracuse, NY, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- April 1, 2009
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- M12A HOLTER SYSTEM SOFTWARE
- PCH100 LAN-3 USER HOLTER S/W
- PCH100 STANDALONE HOLTER S/W
- PCH100/200 DEMO STANDALONE SOFTWARE
- PCH100/200 HOLTER SYSTEM UPGRADE
- PCH100/200 PACEMAKER ANALYSIS OPTION
- PCH200 LAN-3 USER HOLTER S/W
- PCH200 STANDALONE HOLTER S/W
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.