510(k) K233974
- Device
- Mucosal Impedance Measurement System
- Applicant
- Alandra Medical Sapi DE CV
- 510(k) number
- K233974
- Product code
- QIS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-09-06
- Date received
- 2023-12-15
- Regulation
- 876.1450
- Classification name
- Esophageal, Mucosal, Electrical Characterization
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Montserrat Godinez Garcia
- Address
- Bosque De Alisos 17, Oficina 7 Bosques De Las Lomas, Cuajimalpa De Morelos Mexico City MX 05110 05110
FDA Registration Numbers#
- 3009106214
- 2023374