Medical Device Manufacturer · CN , Tiajin

Andon Health Co, Ltd. - FDA 510(k) Cleared Devices

92 submissions · 92 cleared · Since 2008

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. General Hospital ✕

6 devices

1-6 of 6

Cleared Jan 28, 2022

iHealth infrared Ear thermometer PT5

General Hospital · 165d

Cleared Mar 08, 2021

iHealth Wireless No-Touch Forehead Thermometer

General Hospital · 168d

Cleared Jan 05, 2021

iHealth Clinical Digital Thermometer

General Hospital · 105d

Cleared Oct 07, 2020

Livocare Surgical Mask

General Hospital · 134d

Cleared Oct 01, 2020

Infrared PT2L Digital No-Touch Thermometer

General Hospital · 197d

Cleared Jul 15, 2020

iHealth Infrared No-Touch Forehead Thermometer

General Hospital · 135d