Medical device licence · 60425 · Class 2
HOLTER LX
No longer licensed: cancelled: quality-system requirement (2003)
Licence status Cancelled: quality-system requirement (2003); first licensed September 6, 2002; ended February 16, 2004. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 60425
- Licence holder
- Northeast Monitoring, Inc.Maynard, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- September 6, 2002
- Ended
- February 16, 2004
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HOLTER LX - ENHANCED - USB
- HOLTER LX - PRO
- HOLTER LX - PRO - USB
- HOLTER LX BASIC SOFTWARE
- HOLTER LX ENHANCED SOFTWARE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.