FDA 510(k) Application Details - DEN220065

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN220065
Device Name	Pill Sense System
Applicant	EnteraSense Ltd. Unit 3 Ballybrit Business Park, Mervue Galway H91 DT7C IE Other 510(k) Applications for this Company
Contact	David Collins Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QUD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2022
Decision Date	02/24/2023
Decision	DENG -
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review