Device Classification Name |
System, Imaging, Gastrointestinal, Wireless, Capsule
More FDA Info for this Device |
510(K) Number |
K123428 |
Device Name |
System, Imaging, Gastrointestinal, Wireless, Capsule |
Applicant |
INTROMEDIC CO., LTD
STE 1104, E&C VENTURE DREAM TOWER 6-CHA
197-28 GURO-DONG
GURO-GU , SEOUL 152-719 KR
Other 510(k) Applications for this Company
|
Contact |
STEVE KWON
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 |
11/07/2012 |
Decision Date |
05/20/2013 |
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 |
|