📋 FDA Reference
Aerotel Telelink Ecg Telephonic Receiving Interface
Aerotel
Summary: The Aerotel Telelink ECG Telephonic Receiving Interface is a device used for remote ECG monitoring, primarily by cardiologists and healthcare providers in telemedicine settings. It facilitates the transmission of ECG data over telephonic lines for diagnostic purposes.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K961362 ↗
Decision Date ?
July 10, 1996
Product Code ?
DXH
Device Class ?
Class 2
Evidence ?
0 studies
The Aerotel Telelink ECG Telephonic Receiving Interface was cleared through the FDA 510(k) pathway on July 10, 1996. It is manufactured by Aerotel and classified as a Class 2 medical device under product code DXH.
What It Is
The Aerotel Telelink ECG Telephonic Receiving Interface is a medical device designed to receive and transmit ECG signals via telephonic communication. It enables remote monitoring of cardiac activity, allowing healthcare providers to assess heart rhythms without the patient being physically present. This device is particularly useful in telemedicine and home healthcare settings, providing a reliable method for continuous cardiac monitoring.
FDA-Cleared Indications
- Receiving ECG data transmitted through a telephonic communication system for remote review.
- Supporting remote monitoring of cardiac electrical activity in patients requiring ECG assessment.
- Use by healthcare professionals for diagnostic evaluation of transmitted ECG signals.
Clinical Applications
- Remote review of ECG recordings from patients outside a healthcare facility.
- Telemedicine-based assessment of cardiac rhythm and transmitted ECG data.
- Home-health monitoring for patients who need ECG evaluation without frequent in-person visits.
- Transmission of ECG information to cardiologists or other qualified healthcare professionals for interpretation.
Practical Considerations
- The interface is intended to receive transmitted ECG information; it does not replace proper ECG acquisition, lead placement, or clinical interpretation.
- Compatibility with the patient's ECG monitor, telephone connection, connectors, and transmission format should be confirmed before use.
- Accurate transmission depends on adequate electrode placement, signal quality, device setup, and a functioning telephone connection.
- This is not an implanted device and does not involve vascular access, contrast, radiation, or MRI scanning of the interface itself.
- The record does not specify device dimensions, patient-contact components, service life, or current communications compatibility; consult the applicable manufacturer documentation.
Frequently Asked Questions
What is the Aerotel Telelink ECG Telephonic Receiving Interface used for?
It is used for remote monitoring of ECG signals, allowing healthcare providers to assess heart rhythms from a distance.
What specialties typically use this device?
Cardiology and telemedicine professionals commonly use this device for monitoring cardiac patients remotely.
What are the FDA-cleared indications?
The device is indicated for remote monitoring of ECG signals in patients with cardiac conditions, particularly those requiring continuous monitoring.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.