Life-Tel Cellular Transceiver
by Racom, Inc.
510(k) K900541
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK900541 | Date13 Jul 1990 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DXH
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2920
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Life-Tel Cellular Transceiver is a Transmitter and Receiver designed for electrocardiograph (ECG) data transmission via telephone networks. It facilitates wireless communication of cardiac monitoring signals, enabling remote transmission of ECG data for diagnostic evaluation in cardiovascular settings. The device operates as a dedicated cellular modem to relay real-time cardiac information between monitoring equipment and healthcare providers or central monitoring stations.
This device is supplied as a reusable, non-sterile medical electronic component intended for clinical use in cardiovascular monitoring environments. It is classified under FDA regulation 870.2920 and was granted FDA 510(k) clearance (K900541) as substantially equivalent to a predicate device. The transceiver requires proper installation and integration with ECG systems, adhering to manufacturer instructions for calibration and maintenance. No specific MRI safety classification or sterility requirements are noted in the regulatory data.
Other devices from Racom, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Life-Tel Cellular Transceiver used for?
The Life-Tel Cellular Transceiver is designed to transmit electrocardiograph (ECG) data wirelessly over telephone networks. It acts as a dedicated cellular modem to relay real-time cardiac monitoring signals from ECG systems to healthcare providers or central monitoring stations. This facilitates remote diagnostic evaluation in cardiovascular care environments.
Is the Life-Tel Cellular Transceiver reusable or single-use?
The Life-Tel Cellular Transceiver is supplied as a reusable medical electronic component. It is intended for clinical use in cardiovascular monitoring settings and requires proper installation, integration, and maintenance as outlined by the manufacturer.
What are the sterility and MRI safety considerations for this device?
The Life-Tel Cellular Transceiver is non-sterile and not intended for sterile procedures. There is no specific MRI safety classification mentioned in the regulatory data, so it should not be used in MRI environments unless explicitly approved for such use by the manufacturer.
How does one integrate the Life-Tel Cellular Transceiver with ECG systems?
The device requires proper installation and integration with ECG systems according to the manufacturer’s instructions. Calibration and maintenance must be performed as specified to ensure accurate transmission of ECG data. Consult Racom, Inc.’s guidelines for detailed setup procedures.
What regulatory approval does the Life-Tel Cellular Transceiver hold?
The Life-Tel Cellular Transceiver was granted FDA 510(k) clearance (K900541) under the classification for Transmitters and Receivers, Electrocardiograph, Telephone. It is classified under FDA regulation 870.2920 and is considered substantially equivalent to a predicate device.