FDA 510(k) Applications Submitted by Li Yi
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K210663 |
03/05/2021 |
Dermatological Diode Laser Systems |
Beijing HuaCheng Taike Technology Co., Ltd. |
| K140418 |
02/18/2014 |
POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE |
WRP RUBBER PRODUCTS SDN BHD |
| K110018 |
01/03/2011 |
FULLY 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 |
| K160014 |
01/04/2016 |
iHealth Track Blood Pressure Monitor |
Andon Health Co., Ltd |
| K150043 |
01/09/2015 |
Transcutaneous Electrical Nerve Stimulators (TENS) |
ANDON HEALTH CO.,LTD |
| K140121 |
01/16/2014 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON HEALTH CO., LTD |
| K030358 |
02/03/2003 |
KD-622 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
| K030359 |
02/03/2003 |
KD-726 MEMORY WRIST AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
| K110328 |
02/03/2011 |
ACG-8511 PORTABLE ECG MONITOR |
ANDON HEALTH CO.,LTD |
| K110330 |
02/03/2011 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON HEALTH CO.,LTD |
| K070395 |
02/09/2007 |
KD-525E FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
| K160565 |
02/29/2016 |
Fully Automatic Electronic Blood Pressure Monitor |
ANDON HEALTH CO., LTD |
| K160563 |
02/29/2016 |
Fully Automatic Electronic Blood Pressure Monitor |
ANDON HEALTH CO., LTD |
| K200531 |
03/02/2020 |
iHealth Infrared No-Touch Forehead Thermometer |
Andon Health Co., Ltd. |
| K210770 |
03/15/2021 |
Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor |
Andon Health Co., Ltd. |
| K210768 |
03/15/2021 |
Wrist Blood Pressure Monitor, Blood Pressure Monitor |
Andon Health Co., Ltd. |
| K200710 |
03/18/2020 |
Infrared PT2L Digital No-Touch Thermometer |
Andon Health Co., Ltd. |
| K090771 |
03/23/2009 |
FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL, KD-5962 |
ANDON HEALTH CO.,LTD |
| K090768 |
03/23/2009 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD 5901, KD-7909, |
ANDON HEALTH CO.,LTD |
| K090772 |
03/23/2009 |
FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5903, KD-5909 |
ANDON HEALTH CO.,LTD |
| K090770 |
03/23/2009 |
FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5905 |
ANDON HEALTH CO.,LTD |
| K090769 |
03/23/2009 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7961 |
ANDON HEALTH CO.,LTD |
| K070826 |
03/26/2007 |
KD-795 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR |
KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
| K070828 |
03/26/2007 |
KD-595 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
| K120896 |
03/26/2012 |
WI-FI BODY SCALE |
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 |
| K171062 |
04/10/2017 |
BP5S Wireless Blood Pressure Monitor |
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 |
| 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 |
| K091500 |
05/21/2009 |
MODIFICATION TO:FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556 |
ANDON HEALTH CO.,LTD |
| K201380 |
05/26/2020 |
Livocare Surgical Mask |
Andon Health Co., Ltd. |
| K151460 |
06/01/2015 |
Fully Automatic Electronic Blood Pressure Monitor |
ANDON HEALTH CO., LTD. |
| K121697 |
06/07/2012 |
FINGERTIP PULSE OXIMETER |
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 |
| K091738 |
06/11/2009 |
SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-388BD |
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 |
| 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 |
| K051847 |
07/07/2005 |
KD-768 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR |
KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
| 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 |
| K141984 |
07/21/2014 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON HEALTH CO., LTD |
| K162144 |
08/01/2016 |
iHealth Wireless Blood Pressure Monitor |
ANDON HEALTH CO.,LTD |
| K162230 |
08/08/2016 |
Fully Automatic Electronic Blood Pressure Monitor |
ADON HEALTH CO., LTD. |
| K212598 |
08/16/2021 |
iHealth infrared Ear thermometer PT5 |
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 |
| K102356 |
08/19/2010 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534 |
ANDON HEALTH CO.,LTD |
| K102353 |
08/19/2010 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-513 |
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 |
| K042418 |
09/03/2004 |
KD-575 MEMORY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
| K052450 |
09/07/2005 |
KD-788 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR |
KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
| K102609 |
09/10/2010 |
KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON MEDICAL 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 |
| K172862 |
09/20/2017 |
Portable ECG Monitor (ECG3) |
Andon Health Co., Ltd. |
| K202753 |
09/21/2020 |
iHealth Wireless No-Touch Forehead Thermometer |
Andon Health Co., Ltd. |
| K202791 |
09/22/2020 |
iHealth Clinical Digital Thermometer |
Andon Health Co., Ltd. |
| K222867 |
09/22/2022 |
AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) |
Andon Health Co., Ltd. |
| K222869 |
09/22/2022 |
Arm Blood Pressure Monitor |
Andon Health Co., Ltd. |
| K162668 |
09/26/2016 |
Fully Automatic Electronic Blood Pressure Monitor |
ANDON HEALTH CO.,LTD |
| K052676 |
09/27/2005 |
KD-322 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
| K133117 |
09/30/2013 |
ANDON BLOOD PRESSURE CUFF |
ANDON HEALTH CO., LTD |
| K102906 |
10/01/2010 |
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 |
| K102930 |
10/04/2010 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON HEALTH CO.,LTD |
| K162915 |
10/17/2016 |
Fully Automatic Electronic Blood Pressure Monitor |
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 |
| K083246 |
11/03/2008 |
FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5961 |
ANDON HEALTH CO.,LTD |
| K083247 |
11/03/2008 |
FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7906 |
ANDON HEALTH CO.,LTD |
| K083248 |
11/03/2008 |
FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7902 |
ANDON HEALTH CO.,LTD |
| K093452 |
11/05/2009 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-571, KD-7971 |
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 |
| K083319 |
11/10/2008 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7941 |
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 |
| K183534 |
12/19/2018 |
Fully Automatic Electronic Blood Pressure Monitor |
Andon Health Co., Ltd. |
| K183535 |
12/19/2018 |
Fully Automatic Electronic Blood Pressure Monitor |
Andon Health Co., Ltd. |
| K212363 |
07/30/2021 |
Disposable Medical Nitrile Examination Gloves |
Lanhuo Medical Technology (Jiangsu) Co.,Ltd |
| K102138 |
07/30/2010 |
ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER |
EDAN INSTRUMENTS, INC. |
| K172789 |
09/15/2017 |
Specimen Retrieval Bag |
Beijing HangTian KaDi Technology R&D Institute |
| K172846 |
09/19/2017 |
Uterine Manipulator |
Beijing HangTian KaDi Technology R&D Institute |
|
|
