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FDA 510(k)

Automatic Upper Arm Blood Pressure Monitor

K-Number: K193627 · 2020-07-12

ApplicantDongguan E-Test Technology Co., Ltd.
Decision Date2020-07-12
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Automatic Upper Arm Blood Pressure Monitor is a medical device manufactured by Dongguan E-Test Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-07-12 under approval number K193627. 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 Automatic Upper Arm Blood Pressure Monitor?

Automatic Upper Arm Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2020-07-12. It is manufactured by Dongguan E-Test Technology Co., Ltd.. The 510(k) number is K193627.

When was Automatic Upper Arm Blood Pressure Monitor approved by the FDA?

Automatic Upper Arm Blood Pressure Monitor received FDA 510(k) clearance on 2020-07-12, under approval number K193627.

What company makes Automatic Upper Arm Blood Pressure Monitor?

Automatic Upper Arm Blood Pressure Monitor is manufactured by Dongguan E-Test Technology Co., Ltd..

What is the FDA product code for Automatic Upper Arm Blood Pressure Monitor?

The FDA product code for Automatic Upper Arm 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) PMID: 40406702 Toward a unified gait freeze index: a standardized benchmark for clinical and regulatory evaluations. Frontiers in neurology (2025)

Other Devices by Dongguan E-Test Technology Co., Ltd.

K193621Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318) K193628AGE Automatic Wrist Blood Pressure Monitor K193624Automatic Upper Arm Blood Pressure Monitor K250231Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856)

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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