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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name powered insertion system for a cochlear implant electrode array
De Novo Number DEN190055
Device Name iotaSOFT Insertion System - Drive Unit, Controller and Accessories
Requester
iotamotion, inc.
14 1/2 s clinton st.
iowa city,  IA  52240
Contact chris kaufmann
Regulation Number874.4450
Classification Product Code
QQH  
Date Received12/18/2019
Decision Date 10/01/2021
Decision granted (DENG)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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