FDA 510(k) Applications Submitted by Andon Health Co., Ltd
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K110018 |
01/03/2011 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON HEALTH CO., LTD |
| K160014 |
01/04/2016 |
iHealth Track Blood Pressure Monitor |
Andon Health Co., Ltd |
| K140121 |
01/16/2014 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON HEALTH CO., LTD |
| K160563 |
02/29/2016 |
Fully Automatic Electronic Blood Pressure Monitor |
ANDON HEALTH CO., LTD |
| K160565 |
02/29/2016 |
Fully Automatic Electronic Blood Pressure Monitor |
ANDON HEALTH CO., LTD |
| K120896 |
03/26/2012 |
WI-FI BODY SCALE |
ANDON HEALTH CO., LTD |
| K171282 |
05/01/2017 |
Fully Automatic Blood Pressure Monitor |
Andon Health Co., Ltd |
| K121372 |
05/07/2012 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON HEALTH CO., LTD |
| K121470 |
05/17/2012 |
FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR |
ANDON HEALTH CO., LTD |
| K121697 |
06/07/2012 |
FINGERTIP PULSE OXIMETER |
ANDON HEALTH CO., LTD |
| K111830 |
06/28/2011 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MO |
ANDON HEALTH CO., LTD |
| K141984 |
07/21/2014 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON HEALTH CO., LTD |
| K133117 |
09/30/2013 |
ANDON BLOOD PRESSURE CUFF |
ANDON HEALTH CO., LTD |
| K170231 |
01/25/2017 |
iHealth Align Gluco-Monitoring System (BG1); iHealth Wireless Smart Gluco-Monitoring System (BG5)á |
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 |
| 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 |
| 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 |
| 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 |
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