Medical Device Manufacturer · CN , Hangzhou

Joytech Healthcare Co. , Ltd. - FDA 510(k) Cleared Devices

22 submissions · 22 cleared · Since 2017

Recent clearances: Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L), Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P), Compressor Nebulizer (NB-1100)

Official Website

22

Total

22

Cleared

0

Denied

FDA 510(k) Regulatory Record - Joytech Healthcare Co. , Ltd. General Hospital ✕

7 devices

1-7 of 7

Cleared Jul 08, 2020

Digital Thermometer

General Hospital · 121d

Cleared Nov 18, 2019

Digital Thermometer

General Hospital · 346d

Cleared Jul 26, 2019

Infrared Ear/Forehead Thermometer

General Hospital · 114d

Cleared Feb 28, 2019

Digital Thermometer

General Hospital · 157d

Cleared Oct 29, 2018

Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer

General Hospital · 172d

Cleared Oct 02, 2018

Infrared Ear Thermometer

General Hospital · 161d

Cleared Sep 19, 2017

Digital Thermometer

General Hospital · 278d