FDA 510(k)

Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device

K-Number: K161886 · 2016-10-14

ApplicantGuangdong Transtek Medical Electronics Co., Ltd.

Decision Date2016-10-14

Product CodeDXN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device is a medical device manufactured by Guangdong Transtek Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2016-10-14 under approval number K161886. 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 Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device?

Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device is a medical device that received FDA 510(k) clearance on 2016-10-14. It is manufactured by Guangdong Transtek Medical Electronics Co., Ltd.. The 510(k) number is K161886.

When was Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device approved by the FDA?

Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device received FDA 510(k) clearance on 2016-10-14, under approval number K161886.

What company makes Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device?

Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home 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 Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device?

The FDA product code for Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device is DXN.

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

K181832Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device K202599Transtek Wrist Blood Pressure Monitor K202891Blood Pressure Monitor K220676Blood Pressure Monitor K233130Blood Pressure Monitor K232713Blood Pressure Monitor

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Official Source

View on FDA Database →

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