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FDA 510(k)

Transtek Wrist Blood Pressure Monitor

K-Number: K202599 · 2020-12-06

ApplicantGuangdong Transtek Medical Electronics Co., Ltd.
Decision Date2020-12-06
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Transtek Wrist Blood Pressure Monitor is a medical device manufactured by Guangdong Transtek Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2020-12-06 under approval number K202599. 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 Wrist Blood Pressure Monitor?

Transtek Wrist Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2020-12-06. It is manufactured by Guangdong Transtek Medical Electronics Co., Ltd.. The 510(k) number is K202599.

When was Transtek Wrist Blood Pressure Monitor approved by the FDA?

Transtek Wrist Blood Pressure Monitor received FDA 510(k) clearance on 2020-12-06, under approval number K202599.

What company makes Transtek Wrist Blood Pressure Monitor?

Transtek Wrist Blood Pressure Monitor is manufactured by Guangdong Transtek Medical Electronics Co., Ltd..

What is the FDA product code for Transtek Wrist Blood Pressure Monitor?

The FDA product code for Transtek Wrist Blood Pressure Monitor is DXN.

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Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 41623865 Case Report: Hypertensive encephalopathy presents with complex types of sleep breathing events. Frontiers in cardiovascular medicine (2025)

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

View all 14 devices →

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

View on FDA Database →

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

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