FDA 510(k) Applications Submitted by YI LIU
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K110017 |
01/03/2011 |
AG-608N BLOOD GLUCOSE MONITORING SYSTEM |
ANDON MEDICAL CO., LTD. |
| K170231 |
01/25/2017 |
iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)á |
Andon health Co., Ltd |
| K220447 |
02/16/2022 |
Med-link Disposable ECG Cable and Leadwires |
Shenzhen Med-link Electronics Tech Co., Ltd. |
| K220448 |
02/16/2022 |
Disposable Non-invasive EEG Sensor |
Shenzhen Med-link Electronics Tech Co., Ltd. |
| K120813 |
03/19/2012 |
BLOOD GLUCOSE MONITORING SYSTEM |
ANDON MEDICAL CO., LTD |
| K150833 |
03/30/2015 |
iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System |
ANDON HEALTH CO.,LTD |
| K181070 |
04/23/2018 |
iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) |
Andon health Co., Ltd |
| K131203 |
04/29/2013 |
IHEALTH CLOUD |
ANDON HEALTH CO., LTD |
| K101307 |
05/10/2010 |
BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951 |
ANDON MEDICAL CO., LTD. |
| K181541 |
06/11/2018 |
Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK |
Andon health Co., Ltd |
| K122098 |
07/16/2012 |
APPS-HEALTH01 |
ANDON HEALTH CO., LTD |
| K102678 |
09/16/2010 |
ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE, AG-608 SINGLE & AG-608 MULTI BLOOD GLUCOSE MONITORING SYSTEMS |
ANDON MEDICAL CO., LTD. |
| K093262 |
10/19/2009 |
AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM |
ANDON MEDICAL CO., LTD. |
| K153278 |
11/12/2015 |
Wireless Smart Gluco-Monitoring System |
Andon Health Co., Ltd |
| K153286 |
11/12/2015 |
iHealth Align Gluco-Monitoring system |
Andon health Co., Ltd |
| K093755 |
12/07/2009 |
AG-695 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM/AG-696 SINGLE AND MULTI BLOOD GLUCOSE MONITORING SYSTEM |
ANDON MEDICAL CO., LTD. |
| K133790 |
12/09/2013 |
IHEALTH ALIGN MINI GLUCO-MONITORING SYSTEM |
ANDON HEALTH CO., LTD |
| K153561 |
12/14/2015 |
AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System |
ANDON HEALTH CO., LTD |
| K123935 |
12/20/2012 |
IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM |
ANDON MEDICAL CO., LTD. |
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