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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 1, 2024 | Iotamotion Inc iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controllin Completed |
QQH | None listed |
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