Medical Device Manufacturer · US , San Jose , CA

Sejoy Electronics & Instruments Co., Ltd. - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 2006

Recent clearances: Arm-Type Fully Automatic Digital Blood Pressure Monitor, Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36, Infrared Ear Thermometer

14

Total

14

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sejoy Electronics & Instruments Co., Ltd. General Hospital ✕

6 devices

1-6 of 6

Cleared May 27, 2016

Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333,...

General Hospital · 210d

Cleared Mar 31, 2016

Infrared Ear Thermometer

General Hospital · 153d

Cleared Aug 24, 2011

DIGITAL THERMOMETER MT SERIES

General Hospital · 156d

Cleared Sep 17, 2008

INFRARED EAR THERMOMETER, MODEL ET-101A

General Hospital · 44d

Cleared May 04, 2007

SEJOY DIGITAL THERMOMETER, MT SERIES (MT-201, MT-301, MT-402, MT-403 AND MT-405)

General Hospital · 228d

Cleared Feb 06, 2006

SEJOY, MODEL MT-403

General Hospital · 227d