The following data is part of a De Novo classification by Diversatek Healthcare Inc. with the FDA for Mucosal Integrity Conductivity (mi) Test System.
| DeNovo ID | DEN180067 |
| Device Name: | Mucosal Integrity Conductivity (MI) Test System |
| Classification | Esophageal, Mucosal, Electrical Characterization |
| Applicant | Diversatek Healthcare Inc. 9150 Commerce Center Circle, Suite 500 Highlands Ranch, CO 80129 |
| Contact | Laura L Boll |
| Product Code | QIS |
| CFR Regulation Number | 876.1450 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device 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 Board | Gastroenterology/Urology |
| Classification Advisory | Gastroenterology/Urology |
| Type | Direct |
| Date Received | 2018-12-17 |
| Decision Date | 2019-12-23 |
| Reclassification Order: | Reclassification Order |