ApprovalTrail

Medical device licence · 108985 · Class 2

EK12 ECG ALGORITHM

Yes: licensed in Canada

Licence status Issued (active); first licensed February 27, 2023. It is in Health Canada’s list of active licences.
Licence number
108985
Licence holder
Ge Medical Systems Information Technologies Inc.Milwaukee, WI, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
February 27, 2023
Devices covered
1

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • EK12 ECG ALGORITHM

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.