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DR300 Holter Monitor

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K142424

by North East Monitoring, Inc.

Identifiers

510(k) Number
K142424 FDA 510(k)
FDA Product Code
MWJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2800 FDA 510(k)
Regulation Number
870.2800 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The DR300 Holter Monitor is an ambulatory electrocardiograph designed for continuous cardiac rhythm monitoring outside of a clinical setting. Classified as an ambulatory electrocardiograph (without analysis), it records electrical activity of the heart over extended periods—typically 24 to 48 hours—to detect arrhythmias, ischemia, or other cardiac abnormalities in patients, including infants under 10 kg.

Supplied as a reusable medical device, the DR300 is intended for use in clinical, diagnostic, and research environments under physician supervision. It operates without MRI restrictions and is regulated under FDA 510(k) clearance (K142424) and the Medical Devices Directive (MDD). The device is distributed with accompanying software for data analysis and is classified as a Class II medical device (FDA regulation 870.2800).

Frequently asked questions

What is the primary purpose of the DR300 Holter Monitor, and who should use it?

The DR300 Holter Monitor is designed for continuous cardiac rhythm monitoring outside of a clinical setting, typically for 24 to 48 hours. It records the heart’s electrical activity to detect arrhythmias, ischemia, or other abnormalities in patients, including infants under 10 kg. It is intended for use in clinical, diagnostic, and research environments under physician supervision.

Is the DR300 Holter Monitor reusable or single-use, and how does this affect its use?

The DR300 Holter Monitor is explicitly described as a reusable medical device. This means it is designed for repeated use across multiple patients, provided proper cleaning, maintenance, and sterilization protocols are followed. Reusability ensures cost-effectiveness and reduces waste, but it also requires adherence to strict infection control measures to maintain safety and reliability.

Can the DR300 Holter Monitor be used in environments where MRI scans are performed, and why?

Yes, the DR300 Holter Monitor operates without MRI restrictions. This means it can be used in clinical settings where MRI machines are present without posing a risk of interference or safety hazards to patients or equipment, making it versatile for comprehensive cardiac monitoring.

What regulatory pathways has the DR300 Holter Monitor undergone, and what does this mean for its use?

The DR300 Holter Monitor has received FDA 510(k) clearance (K142424) and complies with the Medical Devices Directive (MDD). This indicates that it has been evaluated and deemed substantially equivalent to a legally marketed predicate device by the FDA, ensuring it meets safety and performance standards. Clinicians can rely on its regulatory status as a Class II device under FDA regulation 870.2800.

How is the DR300 Holter Monitor supplied, and what additional components are included?

The DR300 Holter Monitor is supplied as a reusable device and includes accompanying software for data analysis. This software is essential for interpreting the recorded cardiac rhythms, enabling clinicians to diagnose arrhythmias, ischemia, or other cardiac abnormalities detected during monitoring. The combination of hardware and software ensures comprehensive cardiac evaluation.

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. Sources consulted: Holter Monitor - Event Recorder | NorthEast Monitoring, Northeast monitoring DR300 Manuals | ManualsLib, PDF DR200_300HE_Rev_M - Manuals+, PDF DR200_300HE_Rev_M - Manuals+

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
North East Monitoring, Inc.

Sources (2)

  • FDA 510(k) K142424 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026