Panels › Ear, Nose, Throat › Product code QQH · Class 2
Powered Insertion System For A Cochlear Implant Electrode Array
Regulation 874.4450
1510(k)s in 12 months (2 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in QQH
| Company | 510(k)s | Recalls |
|---|---|---|
| Iotamotion, Inc. | 2 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 9, 2026 | K252339 | iotaSOFT® Insertion System Iotamotion, Inc. | QQH |
| Oct 1, 2021 | DEN190055 | iotaSOFT Insertion System - Drive Unit, Controller and Accessories Iotamotion, Inc. | QQH |
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