FDA 510(k)

Microlife Upper Arm Automatic Digital Blood Pressure Monitor

K-Number: K200297 · 2020-06-18

ApplicantMicrolife Intellectual Property GmbH

Decision Date2020-06-18

Product CodeDXN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Microlife Upper Arm Automatic Digital Blood Pressure Monitor is a medical device manufactured by Microlife Intellectual Property GmbH. It received FDA 510(k) clearance on 2020-06-18 under approval number K200297. 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 Upper Arm Automatic Digital Blood Pressure Monitor?

Microlife Upper Arm Automatic Digital Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2020-06-18. It is manufactured by Microlife Intellectual Property GmbH. The 510(k) number is K200297.

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

Microlife Upper Arm Automatic Digital Blood Pressure Monitor received FDA 510(k) clearance on 2020-06-18, under approval number K200297.

What company makes Microlife Upper Arm Automatic Digital Blood Pressure Monitor?

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

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

The FDA product code for Microlife Upper Arm Automatic Digital Blood Pressure Monitor is DXN.

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Other Devices by Microlife Intellectual Property GmbH

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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.