Medical Device Manufacturer · CN , Hangzhou

Hangzhou Hua'An Medical&Health Instruments Co.,Ltd - FDA 510(k) Clear...

3 submissions · 3 cleared · Since 2016

Recent clearances: Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Hangzhou Hua'An Medical&Health Instruments Co.,Ltd General Hospital ✕

3 devices

1-3 of 3

Cleared Feb 13, 2018

Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G,...

General Hospital · 146d

Cleared Dec 19, 2017

Digital thermometer(with disposable thermometer cover)

General Hospital · 90d

Cleared Aug 01, 2016

Infra-red forehead thermometer

General Hospital · 112d