FDA 510(k) Application Details - K234107

Device Classification Name	Monitor, Esophageal Motility, And Tube   More FDA Info for this Device
510(K) Number	K234107
Device Name	Monitor, Esophageal Motility, And Tube
Applicant	Laborie Medical Technologies Corp. 180 International Drive Portsmouth, NH 03801 US Other 510(k) Applications for this Company
Contact	Arpit Sisodiya Other 510(k) Applications for this Contact
Regulation Number	876.1725   More FDA Info for this Regulation Number
Classification Product Code	KLA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/2023
Decision Date	04/23/2024
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