FDA 510(k) Application Details - K232925

Device Classification Name	System,Electrogastrography(Egg)   More FDA Info for this Device
510(K) Number	K232925
Device Name	System,Electrogastrography(Egg)
Applicant	Alimetry Ltd. 70 Symonds Street, Bioengineering House, Level 9 Grafton 1010 NZ Other 510(k) Applications for this Company
Contact	Yaara Yarmut Other 510(k) Applications for this Contact
Regulation Number	876.1735   More FDA Info for this Regulation Number
Classification Product Code	MYE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/19/2023
Decision Date	11/17/2023
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