FDA 510(k) Application Details - K212954

Device Classification Name	System,Electrogastrography(Egg)   More FDA Info for this Device
510(K) Number	K212954
Device Name	System,Electrogastrography(Egg)
Applicant	G-Tech Medical 2495 Hospital Drive, Suite 300 Mountain View, CA 94040 US Other 510(k) Applications for this Company
Contact	Steve Axelrod 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	09/16/2021
Decision Date	01/10/2022
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