Medical device licence · 96580 · Class 2
X8 SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed February 22, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 96580
- Licence holder
- Advanced Brain Monitoring, Inc.Carlsbad, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- February 22, 2016
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACCESSORY 50 NIGHT STUDY KIT
- ACCESSORY DUAL LEAD CABLE
- ACCESSORY EFFORT CABLE STANDARD
- ACCESSORY EXTERNAL BATTERY CABLE
- ACCESSORY EXTERNAL BATTERY KIT
- ACCESSORY SP STRIP KIT
- ARM & CHIN EMG CABLE KIT
- DUAL LEAD CABLE KIT
- EFFORT CABLE SINGLE CHANNEL KIT
- ELECTROENCEPHALOGRAPH
- ELECTROENCEPHALOGRAPH VENTILATORY RECORDER
- PSG2 AIRFLOW ADAPTER KIT
- SLEEP PROFILER LE DEVICE KIT
- SLEEP PROFILER PSG2 LE DEVICE KIT
- SLEEP PROFILER RTA SOFTWARE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.