ApprovalTrail

Medical device licence · 87927 · Class 2

PC-ECG 1200 (SOFTWARE)

Yes: licensed in Canada

Licence status Issued (active); first licensed December 23, 2011. It is in Health Canada’s list of active licences.
Licence number
87927
Licence holder
Norav Medical LtdYokneam, Israel
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
December 23, 2011
Devices covered
14

Devices on this licence

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

  • NEMS WEB
  • PC-ECG 1200 - D1
  • PC-ECG 1200 - D2
  • PC-ECG 1200 - D3
  • PC-ECG 1200 - H1 (HEART RATE VARIABILITY)
  • PC-ECG 1200 - I1 (ECG MEASUREMENTS & EXPERT SYSTEM)
  • PC-ECG 1200 - I2 (INTERPRETATION)
  • PC-ECG 1200 - I3 (MEANS INTERPRETATION)
  • PC-ECG 1200 - L1 (LATE PATENTIAL)
  • PC-ECG 1200 - M1 (MONITORING)
  • PC-ECG 1200 - NEMS-A
  • PC-ECG 1200 - NEMS-Q
  • PC-ECG 1200 - S1 (STRESS)
  • PC-ECG 1200 - S2 (ADVANCED STRESS)

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