Mucosal Impedance Measurement System
FDA 510(k) K233974 · Alandra Medical Sapi DE CV
510(k) numberK233974
Submission
- Device name
- Mucosal Impedance Measurement System
- Applicant
- Alandra Medical Sapi DE CV
Mexico City, MX - Received
- December 15, 2023
- Decision date
- September 6, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QIS – Esophageal, Mucosal, Electrical Characterization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1450
- Specialty
- Gastroenterology, Urology
The esophageal tissue characterization system is intended for obtaining measurements of electrical properties within esophageal tissue.
Other 510(k)s with product code QIS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230056 | MiVu Esophageal Endo CapQIS · Traditional | Diversatek Healthcare | 04/25/2023SE |
Questions and answers
When was Mucosal Impedance Measurement System cleared by the FDA?
Mucosal Impedance Measurement System (K233974) received a 510(k) decision of Substantially Equivalent on September 6, 2024, 266 days after the submission was received.
What is the product code of K233974?
The FDA product code is QIS – Esophageal, Mucosal, Electrical Characterization, a Class II (moderate risk) device regulated under 21 CFR 876.1450.