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Euro-Diagnostic Blood Pressure Monitor

by Medi-Swiss Corp.

510(k) K904298

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK904298 Date21 Jun 1991ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXN
Device Class
Class II
Regulation
21 CFR Part 870.1130
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Euro-Diagnostic Blood Pressure Monitor is an automated, non-invasive device designed to measure systolic and diastolic blood pressure. It falls under the category of blood pressure monitors, intended for clinical and home use to assess cardiovascular health by providing accurate readings of arterial pressure in the upper arm or wrist.

This device is supplied as a single-use or reusable unit, depending on the model variant, and is regulated under FDA 510(k) clearance (K904298) with a traditional review process. It is intended for use in clinical settings, patient homes, and healthcare facilities, with no specific MRI safety restrictions noted. Storage and handling follow standard medical device protocols to ensure accuracy and reliability.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of environments or settings can the Euro-Diagnostic Blood Pressure Monitor be used in, and how does this affect its suitability for different users?

    The Euro-Diagnostic Blood Pressure Monitor is designed for use in clinical settings, patient homes, and healthcare facilities, making it versatile for both professional and personal monitoring. Its non-invasive design and automated functionality ensure it can be reliably used by clinicians to assess cardiovascular health in patients, as well as by individuals at home for self-monitoring. The device’s broad applicability aligns with its regulatory clearance for general blood pressure measurement, ensuring it meets standards for accuracy and safety across these varied environments.

  • Is the Euro-Diagnostic Blood Pressure Monitor intended for single-use or reusable applications, and how does this impact its maintenance or replacement needs?

    The Euro-Diagnostic Blood Pressure Monitor is available in both single-use and reusable variants, depending on the specific model. This flexibility allows users to choose based on their needs—single-use models may be preferred for clinical settings where hygiene and infection control are critical, while reusable models could be more cost-effective for frequent home use. Maintenance for reusable units would follow standard medical device protocols to ensure accuracy and reliability, while single-use models would require replacement after each session.

  • What types of blood pressure measurements does the Euro-Diagnostic Blood Pressure Monitor provide, and where on the body can it be used?

    The Euro-Diagnostic Blood Pressure Monitor measures systolic and diastolic blood pressure, which are key indicators of cardiovascular health. It is designed for non-invasive use on either the upper arm or wrist, offering flexibility for different patient preferences and anatomical considerations. This dual-site capability ensures broader applicability, whether for individuals with mobility limitations or those who prefer wrist monitoring for convenience.

  • Are there any special storage or handling requirements for the Euro-Diagnostic Blood Pressure Monitor to maintain its accuracy and functionality?

    While the device’s exact storage specifications aren’t detailed in the provided data, standard medical device protocols should be followed to ensure its accuracy and reliability. This typically includes protecting the device from extreme temperatures, moisture, and physical damage, as well as keeping it in a clean, dry environment when not in use. Proper handling—such as avoiding exposure to liquids or rough treatment—would also be recommended to preserve its performance over time.