ApprovalTrail

Medical device licence · 74311 · Class 2

OBCU (BALLOON CONTROL UNIT)

Yes: licensed in Canada

Licence status Issued (active); first licensed June 21, 2007. It is in Health Canada’s list of active licences.
Licence number
74311
Licence holder
Olympus Medical Systems Corp.Hachioji-Shi, Japan
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
June 21, 2007
Devices covered
3

Devices on this licence

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

  • OBCU (BALLOON CONTROL UNIT) - MAIN UNIT
  • OBCU (BALLOON CONTROL UNIT) - REMOTE CONTROLLER
  • OBCU (BALLOON CONTROL UNIT)- FOOTSWITCH

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