ApprovalTrail

Medical device licence · 93865 · Class 3

MAC 2000 ECG ANALYSIS SYSTEM

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed September 10, 2014; ended December 6, 2024. It is in Health Canada’s archive of licences no longer in force.
Licence number
93865
Licence holder
Ge Medical Systems Information Technologies Inc.Milwaukee, WI, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
September 10, 2014
Ended
December 6, 2024
Devices covered
9

Devices on this licence

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

  • MAC 2000
  • MAC 2000 MEASUREMENT AND INTERPRETATION BY 12SL
  • MAC 2000 MEASUREMENT AND INTERPRETATION BY HEART ALGORITHM
  • MAC 2000 MEASUREMENT BY 12SL ALGORITHM
  • MAC 2000 MEASUREMENT BY HEART ALGORITHM
  • MAC 2000 MEASUREMENT, INTERPRETATION AND ACITIPI BY 12SL
  • MAC 2000 WITH KISS PUMP
  • MAC 2000 WITH STRESS TEST SOFTWARE
  • MAC 2000 WITHOUT KISS PUMP

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