FDA 510(k) Application Details - K170438

Device Classification Name	System, Imaging, Gastrointestinal, Wireless, Capsule   More FDA Info for this Device
510(K) Number	K170438
Device Name	System, Imaging, Gastrointestinal, Wireless, Capsule
Applicant	IntroMedic Co., Ltd. Suite 1105, 1106, E&C Venture Dream Tower 6-Cha Guro-dong,Guro-gu Seoul 08375 KR Other 510(k) Applications for this Company
Contact	Jinyoung Lee Other 510(k) Applications for this Contact
Regulation Number	876.1300   More FDA Info for this Regulation Number
Classification Product Code	NEZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/13/2017
Decision Date	01/30/2018
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