FDA 510(k) Application Details - K240007

Device Classification Name	System, Gastrointestinal Motility (Electrical)   More FDA Info for this Device
510(K) Number	K240007
Device Name	System, Gastrointestinal Motility (Electrical)
Applicant	Laborie Medical Technologies Corp. 180 International Drive Portsmouth, NH 03801 US Other 510(k) Applications for this Company
Contact	Ingrid Dirtzu Other 510(k) Applications for this Contact
Regulation Number	876.1725   More FDA Info for this Regulation Number
Classification Product Code	FFX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/02/2024
Decision Date	05/06/2024
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