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510(k) K230056

MiVu Esophageal Endo Cap by Diversatek Healthcare — Product Code QIS

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 25, 2023
Date Received: January 9, 2023
Clearance Type: Traditional
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.