Device Classification Name |
Monitor, Ultrasonic, Fetal
More FDA Info for this Device |
510(K) Number |
K082480 |
Device Name |
Monitor, Ultrasonic, Fetal |
Applicant |
CONTEC MEDICAL SYSTEM CO., LTD.
SUITE 8D , ZHONGXIN ZHONGSHAN
MANSION, NO. 19, LANE 999,
ZHONG SHAN, SHANGHAI 20030 CN
Other 510(k) Applications for this Company
|
Contact |
Diana Hong
Other 510(k) Applications for this Contact |
Regulation Number |
884.2660
More FDA Info for this Regulation Number |
Classification Product Code |
KNG
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
08/28/2008 |
Decision Date |
02/25/2009 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
OB - Obstetrics/Gynecology |
Review Advisory Committee |
RA - Radiology |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|