De Novo DEN190055
- Device
- iotaSOFT Insertion System - Drive Unit, Controller and Accessories
- Contact
- chris kaufmann
- De Novo number
- DEN190055
- Product code
- QQH
- Regulation
- 874.4450
- Classification name
- powered insertion system for a cochlear implant electrode array
- Decision
- granted (DENG)
- Decision date
- 2021-10-01
- Date received
- 2019-12-18
- Classification advisory
- Ear Nose & Throat
- Review advisory
- Ear Nose & Throat
- Type
- Direct
Current FDA Classification#
- Product code
- QQH
- Device name
- Powered Insertion System For A Cochlear Implant Electrode Array
- Medical specialty
- Ear, Nose, Throat
- Device class
- 2
- Regulation
- 874.4450
- Implant
- N
- Life sustain/support
- N