FDA 510(k) Application Details - K230526

Device Classification Name	More FDA Info for this Device
510(K) Number	K230526
Device Name	TEA Device
Applicant	Transtimulation Research, Inc. 800 Research Parkway, Suite 337 Oklahoma City, OK 73104 US Other 510(k) Applications for this Company
Contact	Jieyun Yin Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QHH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/27/2023
Decision Date	09/14/2023
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