iotaSOFT Insertion System - Drive Unit, Controller and Accessories— 510(k) DEN190055

Name: FDA 510(k) clearance DEN190055
Creator: U.S. Food and Drug Administration
Published: 2021-10-01

Unknown

Iotamotion, Inc.

FDA 510(k) clearance DEN190055 for iotaSOFT Insertion System - Drive Unit, Controller and Accessories, Unknown on 2021-10-01. Applicant: Iotamotion, Inc.. Device class: 2.

Clearance details

Applicant: Iotamotion, Inc.
Product code: Code QQH
Device class: Class 2
Regulation: 21 CFR 874.4450
Advisory panel: Ear, Nose, Throat
Date received: 2019-12-18
Decision date: 2021-10-01
Decision: Unknown
Clearance type: Direct
Location: Iowa City, IA, US

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