Electrocardiograph ECG301
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K232816 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 Electrocardiograph ECG301 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 cycles, enabling clinicians to diagnose arrhythmias, ischemia, and other cardiac conditions by interpreting waveforms such as the P-wave, QRS complex, and T-wave.
This device is intended for use in clinical, hospital, or home settings and is supplied as a reusable medical instrument. It complies with FDA 510K clearance under the Cardiovascular advisory committee and is also authorised under the Medical Device Regulation (MDR). The ECG301 is not specified as single-use or MRI-safe, and no details on sterility or storage conditions are provided in the data.
Frequently asked questions
Is the ECG301 designed for single-use or can it be reused in clinical settings?
The ECG301 is explicitly described as a reusable medical instrument, meaning it is intended for repeated use in clinical, hospital, or home settings after appropriate cleaning and maintenance. There are no indications in the provided data that it is single-use or requires disposal after one use.
What types of cardiac conditions can the ECG301 help diagnose based on its waveform analysis?
The ECG301 records the heart’s electrical activity, allowing clinicians to analyze waveforms like the P-wave, QRS complex, and T-wave to diagnose conditions such as arrhythmias and ischemia. These waveforms provide critical insights into the heart’s rhythm and electrical function, aiding in the identification of abnormalities.
How is the ECG301 authorized for use in different regions, and what regulatory pathways were followed?
The ECG301 holds FDA 510K clearance under the Cardiovascular advisory committee (reviewed as substantially equivalent) and is also authorized under the Medical Device Regulation (MDR). This means it has undergone regulatory evaluation in both the U.S. and EU markets, ensuring compliance with their respective standards for electrocardiograph devices.
Are there specific storage requirements mentioned for the ECG301, or does it require special handling?
The provided data does not specify storage conditions for the ECG301, such as temperature, humidity, or environmental requirements. Since it is a reusable device, proper cleaning and maintenance protocols would typically apply, but no details on storage are included in the documentation.
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
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K232816 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Le Medical Technology Co., Ltd.
Sources (2)
- FDA 510(k) K232816 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026