# Mediblu ECG System

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/mediblu-ecg-system-dps>
- Manufacturer: [Mediblu Medical, LLC](https://devicerts.com/manufacturers/mediblu-medical-llc) (FDA registration: United States)
- Name in the registry: MEDIBLU ECG SYSTEM
- Device class: Class II (US FDA)
- FDA product code: DPS

## Overview

*AI-generated summary, 2026-10-01. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

The Mediblu ECG System is a diagnostic electrocardiograph classified under the FDA’s product code DPS. It is designed to acquire, display, and record electrocardiogram (ECG) signals from adult and pediatric patients using body surface electrodes. The device amplifies and processes electrical signals from the heart to generate a graphical representation of cardiac activity for clinical assessment. Its primary function aligns with standard ECG monitoring devices, enabling real-time cardiac rhythm evaluation and diagnostic interpretation.

The Mediblu ECG System is supplied as a reusable medical device intended for use in clinical settings such as hospitals, emergency rooms, and cardiology clinics. It operates under standard electrical safety standards and is not classified as MRI-safe or MRI-conditional. The system includes multiple models (ME3, ME6P, ME12P, ME15P) tailored for varying patient monitoring needs. Cleared via FDA’s 510(k) pathway (K233266) under the Traditional review process, it adheres to regulatory requirements for Class 2 Cardiovascular devices. Storage and maintenance instructions are manufacturer-specific and must be followed to ensure device integrity and performance.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K233266 · decision 2024-06-12 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K233266 [FDA 510(k)]
- FDA product code: DPS [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 870.2340 [FDA 510(k)]
- Advisory committee: Cardiovascular [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Mediblu ECG System, Mediblu Medical, LLC. deviCERTS medical device catalogue. https://devicerts.com/devices/mediblu-ecg-system-dps (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/mediblu-ecg-system-dps.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/mediblu-ecg-system-dps
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.