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510(k) DEN180067

Mucosal Integrity Conductivity (MI) Test System by Diversatek Healthcare, Inc. — Product Code QIS

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: December 23, 2019
Date Received: December 17, 2018
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Esophageal, Mucosal, Electrical Characterization
Device Class: Class II
Regulation Number: 876.1450
Review Panel: GU
Submission Type

The esophageal tissue characterization system is intended for obtaining measurements of electrical properties within esophageal tissue.