Medical device licence · 91643 · Class 2
SOUNDBITE HEARING SYSTEM
No longer licensed: cancelled
Licence status Cancelled; first licensed July 10, 2013; ended February 11, 2015. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 91643
- Licence holder
- Sonitus Medical, Inc.San Mateo, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 10, 2013
- Ended
- February 11, 2015
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SOUNDBITE BOOT BTE PROGRAMMING CABLE
- SOUNDBITE BTE
- SOUNDBITE CHARGER
- SOUNDBITE CLIENT/SERVER SOFTWARE USB MEDIA
- SOUNDBITE EAR DOMES
- SOUNDBITE G2 DOME
- SOUNDBITE G2 FIRMWARE UPDATE
- SOUNDBITE HEARING SYSTEM
- SOUNDBITE ITM
- SOUNDBITE MICROPHONE TUBE
- SOUNDBITE MICROPHONES
- SOUNDBITE PATIENT FITTING KIT
- SOUNDBITE POWER DOME
- SOUNDBITE PROGRAMMER KIT
- SOUNDBITE USB INSTALL MEDIA
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.