Medical device licence · 96448 · Class 2
QUANTUM NICOLET
Yes: licensed in Canada
Licence status Issued (active); first licensed January 28, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 96448
- Licence holder
- Natus Medical Incorporated Adba Excel-Tech Ltd (Xltek)Oakville, ON, Canada
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- January 28, 2016
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- NEUROWORKS/SLEEPWORKS SOFTWARE
- PATIENT EVENT BUTTON
- PHOTIC STIMULATOR
- QUANTUM NICOLET
- QUANTUM NICOLET BASE UNIT
- QUANTUM NICOLET BREAKOUT ASSEMBLY
- QUANTUM NICOLET MAIN BREAKOUT BOX
- QUANTUM NICOLET PIN BOX
- QUANTUM NICOLET SECOND BREAKOUT BOX ASSEMBLY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.