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Mucosal Integrity Conductivity (MI) Test System

DEN180067 Class II Direct
Decision Date
2019-12-23
Sponsor / Applicant
Diversatek Healthcare, Inc.

Technical Specification

510(k) Submission ID DEN180067
Product Code QIS
Medical Specialty / Panel Gastroenterology, Urology
Regulation Citation 21 CFR 876.1450
Decision Date 2019-12-23
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Mucosal Integrity Conductivity (MI) Test System received FDA 510(k) clearance under submission number DEN180067, sponsored by Diversatek Healthcare, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2019-12-23.

Classification & Regulation

This clearance is catalogued under FDA product code QIS and 21 CFR 876.1450, within the Gastroenterology, Urology review panel as a Class II device.