ApprovalTrail

Medical device licence · 75570 · Class 2

PNEUMO SURE INSUFFLATOR

Yes: licensed in Canada

Licence status Issued (active); first licensed November 9, 2007. It is in Health Canada’s list of active licences.
Licence number
75570
Licence holder
Stryker Endoscopy, A Div. Of Stryker Corp.San Jose, CA, United States
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
November 9, 2007
Devices covered
5

Devices on this licence

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

  • PNEUMO SURE HIGH FLOW INSUFFLATOR - HEATED TUBESET WITH RTP
  • PNEUMO SURE HIGH FLOW INSUFFLATOR - HIGH FLOW II TUBESET
  • PNEUMO SURE HIGH FLOW INSUFFLATOR - MAIN UNIT
  • PNEUMO SURE HIGH FLOW INSUFFLATOR - MODE UPGRADE KIT TO XL
  • PNEUMO SURE HIGH FLOW INSUFFLATOR - TUBESET ADAPTER

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