← Back to catalogue

Digital Electrocardiograph

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K131858

by Guangdong Biolight Meditech Co., Ltd

Identifiers

510(k) Number
K131858 FDA 510(k)
FDA Product Code
DPS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2340 FDA 510(k)
Regulation Number
870.2340 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Digital Electrocardiograph is a medical device classified as an electrocardiograph, designed to record the electrical activity of the heart over time. It provides a graphical representation of the heart’s electrical impulses, enabling clinicians to diagnose arrhythmias, ischemia, and other cardiac conditions by analyzing waveforms such as the P-wave, QRS complex, and T-wave.

This device is intended for use in clinical settings, including hospitals, emergency rooms, and cardiac care units. Supplied as a reusable instrument, it requires proper calibration and maintenance to ensure accurate readings. The device adheres to FDA and MDR regulatory standards, with a clearance type designated as Traditional under the 510(k) pathway, ensuring compliance with cardiovascular device guidelines.

Frequently asked questions

Is this electrocardiograph designed for single-use or can it be reused in a clinical setting?

This Digital Electrocardiograph is supplied as a reusable instrument, meaning it is intended for repeated use in clinical settings like hospitals, emergency rooms, and cardiac care units. Since it is reusable, proper calibration, maintenance, and cleaning protocols must be followed to ensure accurate and reliable recordings of the heart’s electrical activity over time.

What regulatory pathways does this device follow, and how does that affect its use?

This device follows both FDA (510(k) clearance, Traditional pathway) and MDR (Medical Device Regulation) regulatory pathways. The FDA clearance under the Cardiovascular (CV) advisory committee confirms it meets U.S. standards for electrocardiographs, while MDR compliance ensures it adheres to European medical device regulations. These pathways guarantee the device’s safety, performance, and compliance with cardiovascular diagnostic guidelines.

How is the device’s electrical accuracy maintained over time, especially since it’s reusable?

Since this is a reusable electrocardiograph, its accuracy depends on regular calibration and maintenance as outlined in the manufacturer’s instructions. Proper upkeep ensures consistent waveform readings (such as P-wave, QRS complex, and T-wave) for diagnosing conditions like arrhythmias or ischemia. Neglecting maintenance could compromise diagnostic reliability.

What types of clinical environments is this device intended for, and why?

This device is intended for clinical settings including hospitals, emergency rooms, and cardiac care units due to its role in recording and analyzing heart electrical activity. These environments require precise, real-time ECG monitoring to diagnose cardiac conditions like arrhythmias or ischemia, making it essential for high-stakes patient care.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Guangdong Biolight Meditech Co., Ltd
FDA Applicant
Guangdong Biolight Meditech Co., Ltd.

Sources (2)

  • FDA 510(k) K131858 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026