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FDA 510(k)

Electronic Blood Pressure Monitor

K-Number: K212171 · 2021-11-01

ApplicantDongguan Kangweile Electronic Technology Co., Ltd.
Decision Date2021-11-01
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Electronic Blood Pressure Monitor is a medical device manufactured by Dongguan Kangweile Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-01 under approval number K212171. 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 2021-11-01. It is manufactured by Dongguan Kangweile Electronic Technology Co., Ltd.. The 510(k) number is K212171.

When was Electronic Blood Pressure Monitor approved by the FDA?

Electronic Blood Pressure Monitor received FDA 510(k) clearance on 2021-11-01, under approval number K212171.

What company makes Electronic Blood Pressure Monitor?

Electronic Blood Pressure Monitor is manufactured by Dongguan Kangweile Electronic Technology 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 Dongguan Kangweile Electronic Technology Co., Ltd.

K230642Electronic Blood Pressure Monitor

Related Devices (Code: DXN)

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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.

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