ApprovalTrail

Medical device licence · 11979 · Class 2

ECG LEADS/CABLES/ELECTRODES

Yes: licensed in Canada

Licence status Issued (active); first licensed September 23, 1999. It is in Health Canada’s list of active licences.
Licence number
11979
Licence holder
Ge Medical Systems Information Technologies Inc.Milwaukee, WI, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Group Family
First licensed
September 23, 1999
Devices covered
6

Devices on this licence

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

  • DINAMAP MPS LEAD SHIELDED SNAP LEAD SET - ADULT
  • DINAMAP MPS ECG LEAD KIT - PEDIATRIC
  • DINAMAP MPS LEAD EKG AHA KIT - ADULT
  • DINAMAP MPS PREWIRED NEONATAL ELECTRODE - PEDIATRIC
  • DINAMAP MPS SAFETY CABLE - PEDIATRIC
  • DINAMAP MPS SHIELDED PATIENT CABLE - ADULT

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