FDA 510(k) Application Details - K233974

Device Classification Name	More FDA Info for this Device
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 05110 MX Other 510(k) Applications for this Company
Contact	Montserrat Godinez Garcia Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2023
Decision Date	09/06/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review