Mucosal Impedance Measurement System— 510(k) K233974

Name: FDA 510(k) clearance K233974
Creator: U.S. Food and Drug Administration
Published: 2024-09-06

Substantially Equivalent

Alandra Medical Sapi DE CV

FDA 510(k) clearance K233974 for Mucosal Impedance Measurement System, Substantially Equivalent on 2024-09-06. Applicant: Alandra Medical Sapi DE CV. Device class: 2.

Clearance details

Applicant: Alandra Medical Sapi DE CV
Product code: Code QIS
Device class: Class 2
Regulation: 21 CFR 876.1450
Advisory panel: Gastroenterology, Urology
Date received: 2023-12-15
Decision date: 2024-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mexico City, MX

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIS

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K230056 — MiVu Esophageal Endo Cap2023-04-25
DEN180067 — Mucosal Integrity Conductivity (MI) Test System2019-12-23

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