ApprovalTrail

Medical device licence · 14537 · Class 3

ECG ANALYSIS SYSTEMS

Yes: licensed in Canada

Licence status Issued (active); first licensed November 25, 1999. It is in Health Canada’s list of active licences.
Licence number
14537
Licence holder
Ge Medical Systems Information Technologies Inc.Milwaukee, WI, United States
Risk class
Class III (moderate to high risk)
Licence type
Device Group Family
First licensed
November 25, 1999
Devices covered
2

Devices on this licence

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

  • MAC 1600 ECG ANALYSIS SYSTEM
  • MAC 5500 RESTING ECG SYSTEM

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