Microlife Upper Arm Automatic Digital Blood Pressure Monitor

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K171937 ↗

FDA Product Code

DXN

Device Class

Class II

Regulation

21 CFR Part 870.1130

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Microlife Intellectual Property GmbH →

• What is the Microlife Upper Arm Automatic Digital Blood Pressure Monitor used for?

  This device is designed to automatically measure blood pressure on the upper arm, providing digital readings of systolic and diastolic blood pressure as well as pulse rate. It is intended for both home and clinical use.

• Is the Microlife Upper Arm Blood Pressure Monitor single-use or reusable?

  The device is supplied as either a single-use or reusable product depending on the specific model selected. Users should check their particular model's specifications to determine its intended use pattern.

• What are the storage requirements for this blood pressure monitor?

  The device should be stored according to the manufacturer's instructions. It is MRI safe, which indicates it can be used in environments with magnetic resonance imaging equipment when properly stored and maintained.

• What regulatory approval has this device received?

  The Microlife Upper Arm Automatic Digital Blood Pressure Monitor has received FDA 510(k) clearance with product code DXN. This clearance indicates it has been determined to be substantially equivalent to other legally marketed devices.