Transtelephonic ECG Recorder/Transmitter & Receive
510(k) K854013
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK854013 | Date28 Feb 1986 | 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- Withdrawn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, 26 Sep 2026
This device is a transtelephonic electrocardiograph recorder, transmitter, and receiver system used for capturing, transmitting, and receiving cardiac electrical signals over telephone lines. It functions as a diagnostic tool for remote monitoring of heart activity, enabling the transfer of ECG data from a patient site to a clinical or review location.
The system is designed for use in clinical or home settings where ECG data is recorded and transmitted via standard telephone networks for subsequent review and report generation. It is supplied as a single integrated unit with associated software for database management and report editing. The device is classified under product code DXH, regulated under 21 CFR 870.2920, and was authorized through the FDA 510(k) premarket notification process with a traditional clearance pathway.
Questions
AI-generated answers, 26 Sep 2026
What is the primary function of this device?
This device captures, transmits, and receives cardiac electrical signals over telephone lines. It is used for remote monitoring of heart activity, allowing ECG data to be transferred from a patient site to a clinical or review location for diagnostic purposes.
Where can this device be used?
The system is designed for use in both clinical and home settings. It enables ECG data to be recorded and transmitted via standard telephone networks, making it suitable for remote patient monitoring outside of traditional hospital environments.
How is the device supplied?
It is supplied as a single integrated unit that includes associated software for database management and report editing. This means the hardware and necessary software components are provided together as a complete system.
What regulatory pathway was used for this device?
The device was authorized through the FDA 510(k) premarket notification process. It was classified under product code DXH and regulated under 21 CFR 870.2920, with a traditional clearance pathway based on a determination of substantial equivalence.