FDA 510(k)

Mucosal Impedance Measurement System

K-Number: K233974 · 2024-09-06

Decision Date2024-09-06

Product CodeQIS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Mucosal Impedance Measurement System is the device name listed in this FDA 510(k) record. The listed applicant is Alandra Medical Sapi DE CV. It received FDA 510(k) clearance on 2024-09-06 under 510(k) 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. The listed applicant is Alandra Medical Sapi DE CV. The 510(k) number is K233974.

When did Mucosal Impedance Measurement System receive FDA 510(k) clearance?

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

Who is the listed applicant for Mucosal Impedance Measurement System?

The FDA 510(k) record lists Alandra Medical Sapi DE CV as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: QIS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230056MiVu™ Esophageal Endo CapDiversatek Healthcare

Official Source

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