đź“‹ 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
510K
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.
Clinical Applications
This device is commonly used in cardiology to monitor patients with known or suspected arrhythmias. It is particularly beneficial for patients who require long-term monitoring but cannot frequently visit a healthcare facility. The device is used in outpatient settings, home healthcare, and telemedicine services, providing real-time data to cardiologists and other healthcare professionals for timely intervention.
Indications for Use
The FDA-cleared indications for this device include remote monitoring of ECG signals in patients with cardiac conditions. It is suitable for patients who need continuous heart monitoring due to arrhythmias or other cardiac concerns.
Practical Considerations
The Aerotel Telelink ECG Telephonic Receiving Interface is typically compatible with standard ECG leads and telephonic systems. Clinicians should ensure proper lead placement and signal quality for accurate data transmission. It is important to consider the patient's ability to manage the device at home, including ease of use and understanding of the device's operation.
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.