Medical device licence · 34492 · Class 3
SERVO-I VENTILATOR SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed December 3, 2001. It is in Health Canada’s list of active licences.
- Licence number
- 34492
- Licence holder
- Maquet Critical Care AbSolna, Sweden
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 3, 2001
- Devices covered
- 31
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SERVO-I VENTILATOR SYSTEM
- SERVO-I VENTILATOR SYSTEM - AERONEB MODULE
- SERVO-I VENTILATOR SYSTEM - AERONEB MODULE CONTROL CABLE
- SERVO-I VENTILATOR SYSTEM - AIR GAS MODULE
- SERVO-I VENTILATOR SYSTEM - BATTERY MODULE
- SERVO-I VENTILATOR SYSTEM - BI VENT (SOFTWARE OPTION)
- SERVO-I VENTILATOR SYSTEM - CO2 ANALYZER
- SERVO-I VENTILATOR SYSTEM - CO2 ANALYZER MODULE CAPNOSTAT
- SERVO-I VENTILATOR SYSTEM - COMPRESSOR MINI
- SERVO-I VENTILATOR SYSTEM - HELIOX ADAPTER KIT DISS
- SERVO-I VENTILATOR SYSTEM - HIGH PRESSURE HELIOX HOSE
- SERVO-I VENTILATOR SYSTEM - NASAL -CPAP SW OPTION
- SERVO-I VENTILATOR SYSTEM - NAVA CATHETERS
- SERVO-I VENTILATOR SYSTEM - NAVA HW OPTION
- SERVO-I VENTILATOR SYSTEM - NAVA SW OPTION
- SERVO-I VENTILATOR SYSTEM - NEBULIZER
- SERVO-I VENTILATOR SYSTEM - NIV NAVA SOFTWARE OPTION
- SERVO-I VENTILATOR SYSTEM - O2 GAS MODULE
- SERVO-I VENTILATOR SYSTEM - O2 SENSOR OPTION
- SERVO-I VENTILATOR SYSTEM - OPEN LUNG TOOL (SOFTWARE OPTION)
- SERVO-I VENTILATOR SYSTEM - SOFTWARE VERSION 1.3
- SERVO-I VENTILATOR SYSTEM - SOFTWARE VERSION 2.0
- SERVO-I VENTILATOR SYSTEM - SOFTWARE VERSION 3.0
- SERVO-I VENTILATOR SYSTEM - SOFTWARE VERSION 5.0
- SERVO-I VENTILATOR SYSTEM - SOFTWARE VERSION 8.0
- SERVO-I VENTILATOR SYSTEM - STRESS INDEX SOFTWARE OPTION
- SERVO-I VENTILATOR SYSTEM - SW HELIOX OPTION
- SERVO-I VENTILATOR SYSTEM - Y-SENSOR ADULT
- SERVO-I VENTILATOR SYSTEM - Y-SENSOR MODULE
- SERVO-I VENTILATOR SYSTEM - Y-SENSOR NEONATAL
- SERVO-I VENTILATOR SYSTEM - Y-SENSOR SOFTWARE
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “servo-i”. A notice may cover another product or only some lots: read it to see what it covers.
- SERVO-i Ventilator System (2018-03-20)April 13, 2018 · Medical devices · Medical devices · Type II
- SERVO-I Ventilator System - CO2 Analyzer (2015-02-09)February 9, 2015 · Medical devices · Health products · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.