ApprovalTrail

Medical device licence · 79465 · Class 2

HOLTER PATIENT CABLES

Yes: licensed in Canada

Licence status Issued (active); first licensed April 6, 2009. It is in Health Canada’s list of active licences.
Licence number
79465
Licence holder
Global Instrumentation, LlcEast Syracuse, NY, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
April 6, 2009
Devices covered
22

Devices on this licence

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

  • M12R - SURE-LOCK ECG ELECTRODE CLIP
  • M12R 10 LEAD PATIENT CABLE (AHA)
  • M12R 10 LEAD PATIENT CABLE (AHA) CLIP
  • M12R 10 LEAD PATIENT CABLE (IEC)
  • M3R/M12R 7 LEAD PATIENT CABLE (AHA)
  • M3R/M12R 7 LEAD PATIENT CABLE (IEC)
  • M5 2-LEAD PATIENT CABLE AHA
  • M5 2-LEAD PATIENT CABLE IEC
  • M5 3-LEAD PATIENT CABLE AHA
  • M5 3-LEAD PATIENT CABLE IEC
  • M5 4-LEAD PATIENT CABLE (C) IEC
  • M5 4-LEAD PATIENT CABLE (N) IEC
  • M5 4-LEAD PATIENT CABLE (V) AHA
  • M5 4-LEAD PATIENT CABLE RL-LEAD AHA
  • M5 5-LEAD PATIENT CABLE AHA
  • M5 5-LEAD PATIENT CABLE IEC
  • PATIENT CABLE, AHA, HR100
  • PATIENT CABLE, AHA, HR1200
  • PATIENT CABLE, AHA, HR300 & HR1200
  • PATIENT CABLE, IEC, HR100
  • PATIENT CABLE, IEC, HR1200
  • PATIENT CABLE, IEC, HR300 & HR1200

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