FDA 510(k) Applications Submitted by ANDON HEALTH CO.,LTD
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K080326 |
02/06/2008 |
KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON HEALTH CO.,LTD |
| K100014 |
01/04/2010 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-557 |
ANDON HEALTH CO.,LTD |
| K150043 |
01/09/2015 |
Transcutaneous Electrical Nerve Stimulators (TENS) |
ANDON HEALTH CO.,LTD |
| K110330 |
02/03/2011 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON HEALTH CO.,LTD |
| K110328 |
02/03/2011 |
ACG-8511 PORTABLE ECG MONITOR |
ANDON HEALTH CO.,LTD |
| K090770 |
03/23/2009 |
FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5905 |
ANDON HEALTH CO.,LTD |
| K090768 |
03/23/2009 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD 5901, KD-7909, |
ANDON HEALTH CO.,LTD |
| K090769 |
03/23/2009 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7961 |
ANDON HEALTH CO.,LTD |
| K090771 |
03/23/2009 |
FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL, KD-5962 |
ANDON HEALTH CO.,LTD |
| K090772 |
03/23/2009 |
FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5903, KD-5909 |
ANDON HEALTH CO.,LTD |
| K100940 |
04/05/2010 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 |
ANDON HEALTH CO.,LTD |
| K090963 |
04/06/2009 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556 |
ANDON HEALTH CO.,LTD |
| K101010 |
04/12/2010 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL: KD-5963NU, KD-5008 |
ANDON HEALTH CO.,LTD |
| K131111 |
04/19/2013 |
IHEALTH FINGERTIP PULSE OXIMETER |
ANDON HEALTH CO.,LTD |
| K091500 |
05/21/2009 |
MODIFICATION TO:FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556 |
ANDON HEALTH CO.,LTD |
| K091738 |
06/11/2009 |
SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-388BD |
ANDON HEALTH CO.,LTD |
| K091739 |
06/11/2009 |
SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-3917, KD 3909 |
ANDON HEALTH CO.,LTD |
| K091737 |
06/11/2009 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-5917, KD-5915, KD-5031 |
ANDON HEALTH CO.,LTD |
| K111826 |
06/28/2011 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON HEALTH CO.,LTD |
| K091997 |
07/02/2009 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7962 |
ANDON HEALTH CO.,LTD |
| K092045 |
07/06/2009 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-738 AND KD-739 |
ANDON HEALTH CO.,LTD |
| K101950 |
07/12/2010 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-930 |
ANDON HEALTH CO.,LTD |
| K152003 |
07/20/2015 |
iHealth BP3L Wireless Blood Pressure Monitor |
ANDON HEALTH CO.,LTD |
| K162144 |
08/01/2016 |
iHealth Wireless Blood Pressure Monitor |
ANDON HEALTH CO.,LTD |
| K092510 |
08/17/2009 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7901, KD-7905, KD-7911 |
ANDON HEALTH CO.,LTD |
| K102353 |
08/19/2010 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-513 |
ANDON HEALTH CO.,LTD |
| K102356 |
08/19/2010 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534 |
ANDON HEALTH CO.,LTD |
| K152379 |
08/21/2015 |
iHealth View BP7S Wireless Blood Pressure Wrist Monitor |
ANDON HEALTH CO.,LTD |
| K092588 |
08/24/2009 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5910,KD-5911, KD-5918 |
ANDON HEALTH CO.,LTD |
| K102631 |
09/13/2010 |
KD-931D FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON HEALTH CO.,LTD |
| K092811 |
09/14/2009 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7035B, KD-7921, KD-7903 |
ANDON HEALTH CO.,LTD |
| K102690 |
09/17/2010 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON HEALTH CO.,LTD |
| K162668 |
09/26/2016 |
Fully Automatic Electronic Blood Pressure Monitor |
ANDON HEALTH CO.,LTD |
| K102906 |
10/01/2010 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON HEALTH CO.,LTD |
| K102930 |
10/04/2010 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON HEALTH CO.,LTD |
| K102939 |
10/04/2010 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-931 |
ANDON HEALTH CO.,LTD |
| K093387 |
10/30/2009 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5961, KD-5962, KD-5902 |
ANDON HEALTH CO.,LTD |
| K083248 |
11/03/2008 |
FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7902 |
ANDON HEALTH CO.,LTD |
| K083247 |
11/03/2008 |
FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7906 |
ANDON HEALTH CO.,LTD |
| K083246 |
11/03/2008 |
FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5961 |
ANDON HEALTH CO.,LTD |
| K093452 |
11/05/2009 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-571, KD-7971 |
ANDON HEALTH CO.,LTD |
| K083319 |
11/10/2008 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7941 |
ANDON HEALTH CO.,LTD |
| K083317 |
11/10/2008 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5902 |
ANDON HEALTH CO.,LTD |
| K083318 |
11/10/2008 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5904 |
ANDON HEALTH CO.,LTD |
| K093528 |
11/16/2009 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5963, KD-7963 |
ANDON HEALTH CO.,LTD |
| K083395 |
11/17/2008 |
SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-322,KD-622,KD-575,KD-525E,KD-593,KD-595,KD-596,KD-598 |
ANDON HEALTH CO.,LTD |
| K163276 |
11/21/2016 |
Fully Automatic Electronic Blood Pressure Monitor |
ANDON HEALTH CO.,LTD |
| K080319 |
02/06/2008 |
KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON HEALTH CO.,LTD |
| K073030 |
10/26/2007 |
AG-605 BLOOD GLUCOSE MONITORING SYSTEM |
ANDON HEALTH CO.,LTD |
| K120672 |
03/05/2012 |
KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR |
ANDON HEALTH 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 |
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