ApprovalTrail

Medical device licence · 61798 · Class 3

AESPIRE ANESTHESIA MACHINE

Yes: licensed in Canada

Licence status Issued (active); first licensed February 11, 2003. It is in Health Canada’s list of active licences.
Licence number
61798
Licence holder
Datex-Ohmeda, Inc.Madison, WI, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
February 11, 2003
Devices covered
10

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • S/5 AESPIRE 7100 VENTILATOR SOFTWARE
  • S/5 AESPIRE AGSS
  • S/5 AESPIRE ANESTHESIA MACHINE
  • S/5 AESPIRE BREATHING CIRCUIT COMPONENTS
  • S/5 AESPIRE FLOW SENSOR MODULE
  • S/5 AESPIRE GAS CYLINDER
  • S/5 AESPIRE HARDWARE
  • S/5 AESPIRE LOCALIZATION KIT FOR CANADA
  • S/5 AESPIRE TROLLEY
  • S/5 AESPIRE VAPORIZER CONFIGURATION

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 “aespire”. A notice may cover another product or only some lots: read it to see what it covers.

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.