Mucosal Integrity Conductivity (MI) Test System

Esophageal, Mucosal, Electrical Characterization

Diversatek Healthcare Inc.

The following data is part of a De Novo classification by Diversatek Healthcare Inc. with the FDA for Mucosal Integrity Conductivity (mi) Test System.

Pre-market Notification Details

DeNovo IDDEN180067
Device Name:Mucosal Integrity Conductivity (MI) Test System
ClassificationEsophageal, Mucosal, Electrical Characterization
Applicant Diversatek Healthcare Inc. 9150 Commerce Center Circle, Suite 500 Highlands Ranch,  CO  80129
ContactLaura L Boll
Product CodeQIS  
CFR Regulation Number876.1450 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardGastroenterology/Urology
Classification AdvisoryGastroenterology/Urology
Date Received2018-12-17
Decision Date2019-12-23
Reclassification Order:Reclassification Order

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