Guangdong Transtek Medical Electronics Co., Ltd. - FDA 510(k) Cleared...
Recent clearances: TeleRPM Gen2 Blood Glucose Monitoring System, Blood Pressure Monitor (TMB-2092-G), Blood Pressure Monitor (BBZ32-AA01)
17
Total
17
Cleared
0
Denied
FDA 510(k) Regulatory Record - Guangdong Transtek Medical Electronics Co., Ltd. Cardiovascular ✕
14 devices
Cleared
Aug 21, 2024
Blood Pressure Monitor (TMB-2092-G)
Cardiovascular
100d
Cleared
Jun 07, 2024
Blood Pressure Monitor (BBZ32-AA01)
Cardiovascular
73d
Cleared
May 31, 2024
Blood Pressure Monitor (TMB-2296-BT)
Cardiovascular
121d
Cleared
Apr 29, 2024
Blood Pressure Monitor (TMB-2287-B)
Cardiovascular
104d
Cleared
Dec 20, 2023
Blood Pressure Monitor
Cardiovascular
84d
Cleared
Nov 28, 2023
Blood Pressure Monitor
Cardiovascular
84d
Cleared
Nov 22, 2023
Blood pressure monitor
Cardiovascular
85d
Cleared
Jun 30, 2023
Blood Pressure Monitor
Cardiovascular
238d
Cleared
Aug 29, 2022
Blood Pressure Monitor
Cardiovascular
174d
Cleared
Mar 09, 2021
Blood Pressure Monitor
Cardiovascular
162d
Cleared
Dec 06, 2020
Transtek Wrist Blood Pressure Monitor
Cardiovascular
89d
Cleared
Apr 09, 2019
Transtek Blood Pressure Monitor
Cardiovascular
274d
Cleared
Oct 14, 2016
Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure...
Cardiovascular
95d
Cleared
Jun 19, 2013
TRANSTEK BLOOD PRESSURE MONITOR
Cardiovascular
35d