Tianjin Empecs Medical Device Co., Ltd. is one of 418 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.
Tianjin Empecs Medical Device Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 BT Blood Glucose Monitoring System, Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Glucose Monitoring System, Medisign MM 1100 BT MULTI Blood Glucose Monitoring System, Medisign MM 1200 BT MULTI Blood Glucose Monitoring System, Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System, MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE MONITORING SYSTEM
4
Total
4
Cleared
0
Denied
Tianjin Empecs Medical Device Co., Ltd. has 4 FDA 510(k) cleared medical devices. Based in Manan-Gu Anyang-Si Gyeonggi-Do, KR.
Historical record: 4 cleared submissions from 2012 to 2017. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Tianjin Empecs Medical Device Co., Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Mdi Consultants, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Tianjin Empecs Medical Device Co., Ltd.
4 devices
Cleared
Jun 07, 2017
Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose...
Chemistry
266d
Cleared
Mar 21, 2017
Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood...
Chemistry
564d
Cleared
Jun 27, 2014
MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE...
Chemistry
247d
Cleared
Feb 28, 2012
MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
279d