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FDA 510(k)

Electronic Blood Pressure Monitor

K-Number: K161845 · 2017-07-31

ApplicantShenzhen Pango Electronic Co., Ltd.
Decision Date2017-07-31
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Electronic Blood Pressure Monitor is a medical device manufactured by Shenzhen Pango Electronic Co., Ltd.. It received FDA 510(k) clearance on 2017-07-31 under approval number K161845. 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 Electronic Blood Pressure Monitor?

Electronic Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2017-07-31. It is manufactured by Shenzhen Pango Electronic Co., Ltd.. The 510(k) number is K161845.

When was Electronic Blood Pressure Monitor approved by the FDA?

Electronic Blood Pressure Monitor received FDA 510(k) clearance on 2017-07-31, under approval number K161845.

What company makes Electronic Blood Pressure Monitor?

Electronic Blood Pressure Monitor is manufactured by Shenzhen Pango Electronic Co., Ltd..

What is the FDA product code for Electronic Blood Pressure Monitor?

The FDA product code for Electronic Blood Pressure Monitor is DXN.

Related Clinical Trials

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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 Shenzhen Pango Electronic Co., Ltd.

K170151Electronic Blood Pressure Monitor K182597Infrared thermometer K200716Electronic Blood Pressure Monitor K203746Venen-trainer (Model: FM150, SFM90)

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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