Medical device licence · 61770 · Class 2
SMARTUSB
No longer licensed: cancelled: quality-system requirement (2003)
Licence status Cancelled: quality-system requirement (2003); first licensed February 5, 2003; ended February 16, 2004. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 61770
- Licence holder
- Intelligent Hearing Systems Corp.Miami, FL, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- February 5, 2003
- Ended
- February 16, 2004
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SMARTUSB - BASE
- SMARTUSB - BONE VIBRATOR
- SMARTUSB - ELECTRODE PACK
- SMARTUSB - HEADPHONES
- SMARTUSB - INSERT EARPHONES
- SMARTUSB - IVRA
- SMARTUSB - OAE DISPOSABLE PROBE TIPS
- SMARTUSB - OAE PROBE
- SMARTUSB - OPTIAMP
- SMARTUSB - SMARTEP
- SMARTUSB - SMARTOAE
- SMARTUSB - SMARTSCREENER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.