510(k) DEN190055 ยท QQH Powered Insertion System For A Cochlear Implant Electrode Array
iotaSOFT Insertion System - Drive Unit, Controller and Accessories
| Applicant | Iotamotion, Inc., Iowa City IA, US |
| Decision | Unknown, Oct 1, 2021 |
| Received | Dec 18, 2019 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN190055
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.