Andon Medical Co., Ltd. is one of 1972 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Andon Medical Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE MONITORING SYSTEM, AG-608N BLOOD GLUCOSE MONITORING SYSTEM
9
Total
9
Cleared
0
Denied
Andon Medical Co., Ltd. has 9 FDA 510(k) cleared medical devices. Based in Tianjin, CN.
Historical record: 9 cleared submissions from 2010 to 2013. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Andon Medical Co., Ltd. Filter by specialty or product code using the sidebar.
1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Andon Medical Co., Ltd.
9 devices
Cleared
Apr 12, 2013
IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM
Chemistry
113d
Cleared
Dec 07, 2012
BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
263d
Cleared
CT
Jan 18, 2012
AG-608N BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
380d
Cleared
Sep 30, 2011
ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE
Chemistry
10d
Cleared
Aug 26, 2011
ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI...
Chemistry
344d
Cleared
Aug 09, 2011
BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951
Chemistry
456d
Cleared
Jul 15, 2011
AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND...
Chemistry
585d
Cleared
Dec 09, 2010
KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
Cardiovascular
90d
Cleared
Jul 13, 2010
AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING...
Chemistry
267d