EEG Telephone Receiver Model AFR-J
by Telediagnostic Systems, Inc.
510(k) K810872
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK810872 | Date1 May 1981 | 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- Withdrawn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, 19 Sep 2026
The EEG Telephone Receiver Model AFR-J is a medical device classified as a Transmitter and Receiver for electrocardiograph and electroencephalograph (EEG) signals, designed to transmit recorded data over telephone lines. It facilitates remote monitoring and transmission of EEG readings, enabling healthcare providers to review diagnostic information without physical patient presence.
This device is intended for use in clinical settings where EEG monitoring is conducted, typically in hospitals or specialized diagnostic centers. Supplied as a reusable medical instrument, it requires proper maintenance and calibration to ensure accurate signal transmission. The device holds an FDA 510(k) clearance (K810872) under the classification of Transmitters and Receivers, Electrocardiograph, Telephone, with a regulatory focus on cardiovascular applications. It adheres to FDA regulation 870.2920 and was granted Substantially Equivalent status in 1981.