Medical device licence · 73726 · Class 2
ARIA
Yes: licensed in Canada
Licence status Issued (active); first licensed April 5, 2007. It is in Health Canada’s list of active licences.
- Licence number
- 73726
- Licence holder
- Intelligent Hearing Systems Corp.Miami, FL, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- April 5, 2007
- Devices covered
- 19
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 3-ELECTRODE LEAD PATIENT CABLE
- 3-SNAP LEAD PATIENT CABLE
- ARIA
- BONE VIBRATOR
- BONE VIBRATOR CABLE FOR ARIA
- BONE VIBRATOR HEADBAND
- BONE VIBRATOR W/CABLE AND HEADBAN (B81) FOR ARIA
- DD45-300 HEADPHONES
- EARHUG ADAPTOR WITH TUBES
- EARHUGS
- EARPHONE EXTENSION CABLE
- ER3C INSERT EARPHONES
- HEADPHONE CONNECTOR CONVERTER BOX
- LOOPBACK BOX FOR ARIA
- OAE PROBE
- OAE PROBE STARTUP KIT
- PATIENT EXTENSION CABLE
- PLUG LEAD STARTUP KIT
- USB CABLE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.