QIS
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Esophageal, Mucosal, Electrical Characterization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1450
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- The esophageal tissue characterization system is intended for obtaining measurements of electrical properties within esophageal tissue.
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| Record | Firm | Date |
|---|---|---|
| Mucosal Impedance Measurement System (K233974) | Alandra Medical Sapi DE CV | 2024-09-06 |
| MiVu™ Esophageal Endo Cap (K230056) | Diversatek Healthcare | 2023-04-25 |
| Mucosal Integrity Conductivity (MI) Test System (DEN180067) | Diversatek Healthcare, Inc. | 2019-12-23 |
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Every clearance here is in the API, with alerts when new ones post.