K233974
- 510(k) number
- K233974
- Device name
- Mucosal Impedance Measurement System
- Applicant
- Alandra Medical Sapi DE CV MX
- Product code
- QIS — Esophageal, Mucosal, Electrical Characterization
- Decision date
- 2024-09-06
- Date received
- 2023-12-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K233974.pdf
Official FDA record: K233974
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.