FDA 510(k)

Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device

K-Number: K181832 · 2019-04-09

ApplicantGuangdong Transtek Medical Electronics Co., Ltd.

Decision Date2019-04-09

Product CodeDXN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device is a medical device manufactured by Guangdong Transtek Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2019-04-09 under approval number K181832. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device?

Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device is a medical device that received FDA 510(k) clearance on 2019-04-09. It is manufactured by Guangdong Transtek Medical Electronics Co., Ltd.. The 510(k) number is K181832.

When was Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device approved by the FDA?

Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device received FDA 510(k) clearance on 2019-04-09, under approval number K181832.

What company makes Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device?

Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device is manufactured by Guangdong Transtek Medical Electronics Co., Ltd..

What is the FDA product code for Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device?

The FDA product code for Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device is DXN.

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Other Devices by Guangdong Transtek Medical Electronics Co., Ltd.

K161886Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device K202599Transtek Wrist Blood Pressure Monitor K202891Blood Pressure Monitor K220676Blood Pressure Monitor K233130Blood Pressure Monitor K232713Blood Pressure Monitor

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Related Devices (Code: DXN)

K162092Evolv Model BP7000 Upper Arm Blood Pressure MonitorOmron Healthcare, Inc. K161708Arm automatic blood pressure monitorShenzhen Pump Medical System Co., Ltd. K162230Fully Automatic Electronic Blood Pressure MonitorAdon Health Co., Ltd. K160349Electronic SphygmomanometerGuangdong Biolight Meditech Co., Ltd. K161846Automatic Arm Bluetooth Blood Pressure MonitorTruly Instrument Limited K161886Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure DeviceGuangdong Transtek Medical Electronics Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.