ApprovalTrail

Medical device licence · 87480 · Class 2

SLEEPIMAGE KITS

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed October 24, 2011; ended November 1, 2021. It is in Health Canada’s archive of licences no longer in force.
Licence number
87480
Licence holder
Mycardio LlcDenver, CO, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Group Family
First licensed
October 24, 2011
Ended
November 1, 2021
Devices covered
11

Devices on this licence

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

  • ACCESSORY KIT
  • CONSUMABLE REPLACEMENT KIT
  • CONSUMABLE STARTER KIT
  • M1 SLEEP RECORDER KIT
  • M1 SLEEP RECORDER KIT, RENTAL
  • PATIENT TEST KIT
  • SLEEP DATA RECORDER ELECTRODES
  • SLEEP DATA RECORDER TEST KIT
  • SLEEPIMAGE ADD ON MULTI SITE
  • SLEEPIMAGE ADD ON SINGLE SITE
  • SLEEPIMAGE SYSTEM STARTER KIT

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