K-number	DEN190055
Device name	iotaSOFT Insertion System - Drive Unit, Controller and Accessories
Applicant	Iotamotion, Inc.
Product code	QQH
Device class	Class II
Decision date	Oct 1, 2021
Decision	Not Substantially Equivalent
Regulation	—

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View the full FDA submission: accessdata.fda.gov

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iotaSOFT Insertion System - Drive Unit, Controller and Accessories

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