Panels › Gastroenterology, Urology › Product code QIS · Class 2
Esophageal, Mucosal, Electrical Characterization
Regulation 876.1450
0510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QIS
| Company | 510(k)s | Recalls |
|---|---|---|
| Diversatek Healthcare | 2 | 0 |
| Alandra Medical Sapi DE CV | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 6, 2024 | K233974 | Mucosal Impedance Measurement System Alandra Medical Sapi DE CV, MX | QIS |
| Apr 25, 2023 | K230056 | MiVu Esophageal Endo Cap Diversatek Healthcare | QIS |
| Dec 23, 2019 | DEN180067 | Mucosal Integrity Conductivity (MI) Test System Diversatek Healthcare, Inc. | QIS |
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