# K953762: Heart 400 Ecg Transmitter

- Pathway: 510(k) (Traditional)
- Applicant: Aerotel, Ltd.
- Decided: Jul 18, 1996 after 342 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 K931020 (1995). 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)
- K931020: HEART 1001, Aerotel, Ltd. (1995) Summary page 1.

## Indications for use
The H400 is a battery powered 3-lead Transtelephonic ECG Transmitter which is intended to be used by the patient to transmit via the telephone a patient's electrocardiogram (ECG) to a receiving center such a Aerotel's Heartline 3000 (FDA # K930314) or equivalent. The device is not intended to be used for long-term monitoring or when the patient is not capable of actuating the device or the telephone.

Source page: https://510kreport.com/device/K953762
Methodology: https://510kreport.com/methodology