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FDA 510(k)

Mucosal Impedance Measurement System

K-Number: K233974 · 2024-09-06

ApplicantAlandra Medical Sapi DE CV
Decision Date2024-09-06
Product CodeQIS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Mucosal Impedance Measurement System is a medical device manufactured by Alandra Medical Sapi DE CV. It received FDA 510(k) clearance on 2024-09-06 under approval number K233974. The device is classified under product code QIS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mucosal Impedance Measurement System?

Mucosal Impedance Measurement System is a medical device that received FDA 510(k) clearance on 2024-09-06. It is manufactured by Alandra Medical Sapi DE CV. The 510(k) number is K233974.

When was Mucosal Impedance Measurement System approved by the FDA?

Mucosal Impedance Measurement System received FDA 510(k) clearance on 2024-09-06, under approval number K233974.

What company makes Mucosal Impedance Measurement System?

Mucosal Impedance Measurement System is manufactured by Alandra Medical Sapi DE CV.

What is the FDA product code for Mucosal Impedance Measurement System?

The FDA product code for Mucosal Impedance Measurement System is QIS.

Related Clinical Trials

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Related PubMed Literature

PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

Related Devices (Code: QIS)

DEN180067Mucosal Integrity Conductivity (MI) Test SystemDiversatek Healthcare, Inc. K230056MiVu™ Esophageal Endo CapDiversatek Healthcare

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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