FDA 510(k) Applications Submitted by ANDON HEALTH CO., LTD.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K200531 |
03/02/2020 |
iHealth Infrared No-Touch Forehead Thermometer |
Andon Health Co., Ltd. |
| K210768 |
03/15/2021 |
Wrist Blood Pressure Monitor, Blood Pressure Monitor |
Andon Health Co., Ltd. |
| K210770 |
03/15/2021 |
Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor |
Andon Health Co., Ltd. |
| K200710 |
03/18/2020 |
Infrared PT2L Digital No-Touch Thermometer |
Andon Health Co., Ltd. |
| K171062 |
04/10/2017 |
BP5S Wireless Blood Pressure Monitor |
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. |
| K212598 |
08/16/2021 |
iHealth infrared Ear thermometer PT5 |
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. |
| K162915 |
10/17/2016 |
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. |
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