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FDA 510(k)

Bluetooth blood pressure monitor

K-Number: K171668 · 2018-02-26

ApplicantVisiomed Group SA
Decision Date2018-02-26
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Bluetooth blood pressure monitor is a medical device manufactured by Visiomed Group SA. It received FDA 510(k) clearance on 2018-02-26 under approval number K171668. 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 Bluetooth blood pressure monitor?

Bluetooth blood pressure monitor is a medical device that received FDA 510(k) clearance on 2018-02-26. It is manufactured by Visiomed Group SA. The 510(k) number is K171668.

When was Bluetooth blood pressure monitor approved by the FDA?

Bluetooth blood pressure monitor received FDA 510(k) clearance on 2018-02-26, under approval number K171668.

What company makes Bluetooth blood pressure monitor?

Bluetooth blood pressure monitor is manufactured by Visiomed Group SA.

What is the FDA product code for Bluetooth blood pressure monitor?

The FDA product code for Bluetooth 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)

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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