Medical device licence · 94391 · Class 2
NATUS QUANTUM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 15, 2014. It is in Health Canada’s list of active licences.
- Licence number
- 94391
- 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
- December 15, 2014
- Devices covered
- 16
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- MONOPUTER
- NATUS QUANTUM
- NATUS QUANTUM BASE UNIT
- NATUS QUANTUM BREAKOUT BOX
- NATUS QUANTUM BREAKOUT CABLE
- NATUS QUANTUM BREAKOUT TO BASE CABLE
- NATUS QUANTUM CABLE
- NATUS QUANTUM OXIMETER ADAPTER
- NATUS QUANTUM PATIENT EVENT BUTTON
- NATUS QUANTUM PIN BOX
- NATUS QUANTUM REF JUMPER CABLE
- NEUROWAND PORTABLE VIDEO CART
- NEUROWORKS/SLEEPWORKS SOFTWARE
- PHOTIC STIMULATOR
- POWER CORD
- QUANTUM BREAKOUT ASSEMBLY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.