Truly Instrument Limited is one of 1554 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Truly Instrument Limited - FDA 510(k) Cleared Devices
Recent clearances: Infrared Thermometer TET-351, Arm Blood Pressure Monitor
5
Total
5
Cleared
0
Denied
Truly Instrument Limited has 5 FDA 510(k) cleared medical devices. Based in Shanwei City, Guangdong, CN.
Last cleared in 2023. Active since 2008. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Truly Instrument Limited Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Truly (U.S.A), Inc. and Chonconn Medical Device Consulting Co., Ltd..
FDA 510(k) Regulatory Record - Truly Instrument Limited
5 devices
Cleared
Feb 17, 2023
Infrared Thermometer TET-351
General Hospital
382d
Cleared
Dec 23, 2019
Arm Blood Pressure Monitor
Cardiovascular
147d
Cleared
Oct 24, 2016
Automatic Arm Bluetooth Blood Pressure Monitor
Cardiovascular
111d
Cleared
Jun 24, 2009
TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370
General Hospital
114d
Cleared
Dec 12, 2008
TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11
Cardiovascular
165d