K233974 is an FDA 510(k) clearance for the Mucosal Impedance Measurement System. This device is classified as a Esophageal, Mucosal, Electrical Characterization (Class II - Special Controls, product code QIS).
Submitted by Alandra Medical Sapi DE CV (Mexico City, MX). The FDA issued a Cleared decision on September 6, 2024, 266 days after receiving the submission on December 15, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1450. The Esophageal Tissue Characterization System Is Intended For Obtaining Measurements Of Electrical Properties Within Esophageal Tissue..
| 510(k) Number | K233974 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2023 |
| Decision Date | September 06, 2024 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | QIS - Esophageal, Mucosal, Electrical Characterization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1450 |
| Definition | The Esophageal Tissue Characterization System Is Intended For Obtaining Measurements Of Electrical Properties Within Esophageal Tissue. |