# K032736: HEART 2006

- Pathway: 510(k) (Special)
- Applicant: Aerotel Medical Systems (1998), Ltd.
- Decided: Oct 3, 2003 after 29 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 K000775 (2000). 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)
- K000775: HEART 2005, Aerotel Medical Systems (1998), Ltd. (2000) Summary page 1.

## Indications for use
The Heart 2006 is a long-term portable electrocardiogram monitor intended to be used for long-term cardiac out-patient management. The unit records a period of electrocardiogram whenever the patient feels symptoms, as indicated to him by a physician, and presses a button on the unit. The electrocardiograms are then sent to the physician by telephone. The unit is indicated whenever it is desired to have electrocardiogramsof a symptomatic patient at the time of the symptoms. There are no known contraindications.

Source page: https://510kreport.com/device/K032736
Methodology: https://510kreport.com/methodology