Medical device licence · 78980 · Class 3
ENGSTROM PRO
Yes: licensed in Canada
Licence status Issued (active); first licensed February 6, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 78980
- Licence holder
- Datex-Ohmeda, Inc.Madison, WI, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 6, 2009
- Devices covered
- 14
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ENGSTROM PRO - DISS FEM SEQUENTIAL PROBE, HOSE ASSEMBLIES
- ENGSTROM PRO - EVIEW ASSEMBLY
- ENGSTROM PRO - EXHALATION VALVE HEATER OPTION
- ENGSTROM PRO - EXHALATION VALVE HEATER OPTION CABLE
- ENGSTROM PRO - EXHALATION VALVE KIT
- ENGSTROM PRO - EXPIRATORY FLOW SENSOR
- ENGSTROM PRO - MAIN UNIT
- ENGSTROM PRO - PNEUMATIC/ELECTRICAL CONFIGURATION
- ENGSTROM PRO - SOFTWARE
- ENGSTROM PRO - SOFTWARE FIELD UPGRADE
- ENGSTROM PRO - SOFTWARE OPTION, BI-LEVEL-VG
- ENGSTROM PRO - SOFTWARE OPTION, NIV
- ENGSTROM PRO - SOFTWARE OPTION, SIMV-PCVG
- ENGSTROM PRO - TROLLEY OPTIONS
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 “engstrom”. A notice may cover another product or only some lots: read it to see what it covers.
- Engstrom Pro, Carescape, Engstrom CarestationMay 9, 2022 · Anaesthesiology · Electrical defect · Type II
- Engstrom Carestation (2015-01-29)February 6, 2015 · Medical devices · Health products · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.