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 |
|