# K961362: Aerotel Telelink Ecg Telephonic Receiving Interface

- Pathway: 510(k) (Traditional)
- Applicant: Aerotel, Ltd.
- Decided: Jul 10, 1996 after 92 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K930314 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930314: Heartline Transtelephonic Ecg Receiving Console, Aerotel, Ltd. (1994) Summary page 1.

## Indications for use
The Telelink is a battery powered device intended to be used by the physician in his office, for the transfer of an ECG signal received over the telephone from a compatible transmitter, to a conventional single trace ECG recorder in the physician's office . The patient has no contact with the Telelink, and it does not affect him in any way.

Source page: https://510kreport.com/device/K961362
Methodology: https://510kreport.com/methodology