Andon Health Co, Ltd. - FDA 510(k) Cleared Devices
Recent clearances: iHealth Compare Wireless Blood Pressure Monitor(BP-300C), iHealth® Early Pregnancy Test, Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA)
92
Total
92
Cleared
0
Denied
FDA 510(k) Regulatory Record - Andon Health Co, Ltd. Cardiovascular ✕
72 devices
Cleared
CT
Aug 04, 2025
iHealth Compare Wireless Blood Pressure Monitor(BP-300C)
Cardiovascular
115d
Cleared
Apr 22, 2024
Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA)
Cardiovascular
123d
Cleared
Feb 15, 2023
Arm Blood Pressure Monitor
Cardiovascular
146d
Cleared
Jul 30, 2021
Wrist Blood Pressure Monitor, Blood Pressure Monitor
Cardiovascular
137d
Cleared
Jul 29, 2021
Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor
Cardiovascular
136d
Cleared
Jun 04, 2019
Fully Automatic Electronic Blood Pressure Monitor
Cardiovascular
167d
Cleared
May 16, 2019
Fully Automatic Electronic Blood Pressure Monitor
Cardiovascular
148d
Cleared
Apr 16, 2019
Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native...
Cardiovascular
309d
Cleared
Jul 24, 2018
Portable ECG Monitor (ECG3)
Cardiovascular
307d
Cleared
Aug 01, 2017
BP5S Wireless Blood Pressure Monitor
Cardiovascular
113d
Cleared
Jul 27, 2017
Fully Automatic Blood Pressure Monitor
Cardiovascular
87d
Cleared
CT
May 11, 2017
Fully Automatic Electronic Blood Pressure Monitor
Cardiovascular
171d
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