Auto Detect For Telaheart Dr200/E-A
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K070014 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 Auto Detect for TelHeart DR200/E-A is an Electrocardiograph, Ambulatory (Without Analysis), designed to automatically detect and monitor cardiac rhythms during continuous ambulatory electrocardiographic recording. It functions as an accessory to the TelHeart DR200/E-A system, enhancing its capability to identify arrhythmias or other cardiac events without real-time analysis.
This device is supplied as a reusable accessory for use in clinical and home monitoring settings, adhering to FDA 510K and MDD regulatory standards. It is intended for integration with the TelHeart DR200/E-A system, with no specific sterility requirements stated beyond standard medical device hygiene practices. The device operates within Class II regulatory classification and is authorized under the Medical Device Regulation (MDD) and FDA Traditional 510(k) clearance (K070014).
Frequently asked questions
What is the primary purpose of the Auto Detect for TelHeart DR200/E-A, and how does it enhance the TelHeart system?
The Auto Detect for TelHeart DR200/E-A is designed as an accessory to automatically detect and monitor cardiac rhythms during continuous ambulatory electrocardiographic (ECG) recording. It enhances the TelHeart DR200/E-A system by improving its ability to identify arrhythmias or other cardiac events without requiring real-time analysis, making it more effective for both clinical and home monitoring settings.
Is the Auto Detect for TelHeart DR200/E-A intended for single-use or reusable applications?
The Auto Detect for TelHeart DR200/E-A is explicitly described as a reusable accessory. While it does not require sterilization beyond standard medical device hygiene practices, it is meant for repeated use in clinical and home monitoring environments, ensuring durability and cost-effectiveness for ongoing cardiac monitoring.
What regulatory pathways does the Auto Detect for TelHeart DR200/E-A follow, and which committees or classifications apply?
The device follows the FDA Traditional 510(k) clearance pathway (K070014) and is authorized under the Medical Device Directive (MDD). It is classified as a Class II medical device and falls under the Cardiovascular advisory committee (CV), reflecting its role in ambulatory ECG monitoring for detecting cardiac events.
How should the Auto Detect for TelHeart DR200/E-A be stored, and are there any special handling requirements?
The device does not specify unique storage conditions beyond standard medical device hygiene practices, which typically include clean, dry environments protected from physical damage or contamination. Since it is reusable, proper cleaning and maintenance protocols should be followed to ensure reliable performance in continuous cardiac monitoring applications.
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
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K070014 | Class II | Active |
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Manufacturer
- Manufacturer
- North East Monitoring, Inc.
Sources (2)
- FDA 510(k) K070014 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026