ApprovalTrail

Medical device licence · 61945 · Class 2

ELEMENTS DIAGNOSTIC UNIT

Yes: licensed in Canada

Licence status Issued (active); first licensed March 6, 2003. It is in Health Canada’s list of active licences.
Licence number
61945
Licence holder
Kerr CorporationOrange, California, United States
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
March 6, 2003
Devices covered
7

Devices on this licence

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

  • ELEMENTS DIAGNOSTIC UNIT
  • ELEMENTS DIAGNOSTIC UNIT - BATTERY PACK
  • ELEMENTS DIAGNOSTIC UNIT - BRACKET AND HARDWARE
  • ELEMENTS DIAGNOSTIC UNIT - CORD SET WITH REMOTE
  • ELEMENTS DIAGNOSTIC UNIT - FILE CLIP, PATIENT LEAD AND LIP HOOK
  • ELEMENTS DIAGNOSTIC UNIT - PROBES
  • ELEMENTS DIAGNOSTIC UNIT - TRANSFOMER AND PLUG ADAPTER

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