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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Esophageal, Mucosal, Electrical Characterization
510(k) Number K233974
Device Name Mucosal Impedance Measurement System
Applicant
Alandra Medical Sapi DE CV
Bosque De Alisos 17, Oficina 7
Bosques De Las Lomas, Cuajimalpa De Morelos
Mexico City,  MX 05110
Applicant Contact Montserrat Godinez Garcia
Correspondent
Hogan Lovells US LLP
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact Randy Prebula
Regulation Number876.1450
Classification Product Code
QIS  
Subsequent Product Code
PIF  
Date Received12/15/2023
Decision Date 09/06/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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