Medical device licence · 94571 · Class 2
HOT TOP2 NEBULIZER SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 21, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 94571
- Licence holder
- Intersurgical Ltd.East Syracuse, NY, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- January 21, 2015
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HOT TOP2 ECO ADULT MASK KIT
- HOT TOP2 ECO PEDIATRIC MASK KIT
- HOT TOP2 MOUTHPIECE KIT
- HOT TOP2 NEBULISER
- HOT TOP2 NEBULISER, ADULT, INTERSURGICAL ECOLITE MASK KIT AND TUBE WITH UNIVERSAL CONNECTOR
- HOT TOP2 NEBULISER, PAEDIATRIC, INTERSURGICAL ECOLITE MASK KIT AND TUBE WITH UNIVERSAL CONNECTOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.