ApprovalTrail

Medical device licence · 71409 · Class 2

HEARTWAVE II MTWA SYSTEM

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed May 19, 2006; ended August 20, 2020. It is in Health Canada’s archive of licences no longer in force.
Licence number
71409
Licence holder
Spacelabs Healthcare Ltd. (Hertford)Hertford, HT, United Kingdom
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
May 19, 2006
Ended
August 20, 2020
Devices covered
6

Devices on this licence

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

  • HEARTWAVE II MTWA SYSTEM
  • HEARTWAVE II MTWA SYSTEM - MICRO-V ALTERNANS SENSORS (CASE)
  • HEARTWAVE II MTWA SYSTEM - MICRO-V CABLE
  • HEARTWAVE II MTWA SYSTEM - PM-3 PATIENT MODULE
  • HEARTWAVE II MTWA SYSTEM - SOFTWARE
  • HEARTWAVE II MTWA SYSTEM - STRESS CABLE

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