Medical device licence · 99486 · Class 2
KARDIA MOBILE
Yes: licensed in Canada
Licence status Issued (active); first licensed August 2, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99486
- Licence holder
- Alivecor, Inc.Mountain View, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- August 2, 2017
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- K1000
- KARDIA APP ANDROID
- KARDIA APP IOS
- KARDIA MOBILE
- KARDIAAI
- KARDIAMOBILE 6L
- KARDIAMOBILE 6L MAX
- KARDIAMOBILE CARD
- KARDIARX (ANDROID)
- KARDIARX (IOS)
- KARDIASTATION APP ANDROID
- KARDIASTATION APP IOS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.