FDA Product Code
FDA Product Code QIS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1450
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K233974 | Mucosal Impedance Measurement System | Alandra Medical Sapi DE CV | 2024-09-06 | Traditional | PDF ↗ |
| K230056 | MiVu Esophageal Endo Cap | Diversatek Healthcare | 2023-04-25 | Traditional | PDF ↗ |
| DEN180067 | Mucosal Integrity Conductivity (MI) Test System | Diversatek Healthcare, Inc. | 2019-12-23 | Direct | — |
Product code QIS · Class II · Gastroenterology, Urology. Data: openFDA.