510(k) DEN190055
- Device
- iotaSOFT Insertion System - Drive Unit, Controller and Accessories
- Applicant
- Iotamotion, Inc.
- 510(k) number
- DEN190055
- Product code
- QQH
- Decision
- Unknown (DENG)
- Decision date
- 2021-10-01
- Date received
- 2019-12-18
- Regulation
- 874.4450
- Classification name
- Powered Insertion System For A Cochlear Implant Electrode Array
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Chris Kaufmann
- Address
- 14 1/2 S Clinton St. Iowa City IA US 52240 52240
FDA Registration Numbers#
- 3023531666
- 2030624
- 3030411493
- 3031976597
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QQH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252339 | iotaSOFT® Insertion System | Iotamotion, Inc. | 2026-01-09 |