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FDA 510(k)

Microlife Digital Blood Pressure Monitor

K-Number: K183469 · 2019-03-12

ApplicantMicrolife Intellectual Property GmbH
Decision Date2019-03-12
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Microlife Digital Blood Pressure Monitor is a medical device manufactured by Microlife Intellectual Property GmbH. It received FDA 510(k) clearance on 2019-03-12 under approval number K183469. 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 Microlife Digital Blood Pressure Monitor?

Microlife Digital Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2019-03-12. It is manufactured by Microlife Intellectual Property GmbH. The 510(k) number is K183469.

When was Microlife Digital Blood Pressure Monitor approved by the FDA?

Microlife Digital Blood Pressure Monitor received FDA 510(k) clearance on 2019-03-12, under approval number K183469.

What company makes Microlife Digital Blood Pressure Monitor?

Microlife Digital Blood Pressure Monitor is manufactured by Microlife Intellectual Property GmbH.

What is the FDA product code for Microlife Digital Blood Pressure Monitor?

The FDA product code for Microlife Digital 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 Microlife Intellectual Property GmbH

K153077Microlife Upper Arm Automatic Digital Blood Pressure Monitor K172498Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y K170467Microlife Upper Arm Automatic Digital Blood Pressure Monitor K170219Microlife Digital Infrared Ear Thermometer K172880Microlife Upper Arm Automatic Digital Blood Pressure Monitor K171937Microlife Upper Arm Automatic Digital Blood Pressure Monitor

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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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