FDA 510(k) Application Details - DEN190055

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN190055
Device Name	iotaSOFT Insertion System - Drive Unit, Controller and Accessories
Applicant	IotaMotion, Inc. 14 1/2 S Clinton St. Iowa City, IA 52240 US Other 510(k) Applications for this Company
Contact	Chris Kaufmann Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QQH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/18/2019
Decision Date	10/01/2021
Decision	DENG -
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review