FDA 510(k) Application Details - K240946

Device Classification Name	System,Electrogastrography(Egg)   More FDA Info for this Device
510(K) Number	K240946
Device Name	System,Electrogastrography(Egg)
Applicant	Alimetry Ltd. 70 Symonds Street Grafton 1010 NZ Other 510(k) Applications for this Company
Contact	Yarmut Yaara 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	04/05/2024
Decision Date	07/03/2024
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