Medical device licence · 90539 · Class 2
KAYPENTAX SPEECH THERAPY SOFTWARE
Yes: licensed in Canada
Licence status Issued (active); first licensed January 17, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 90539
- Licence holder
- Pentax Of America, Inc.Montvale, NJ, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- January 17, 2013
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CSL SOFTWARE
- MULTI-SPEECH SOFTWARE
- SONA-SPEECH SOFTWARE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.