# K972587: Electrocardiographs

- Pathway: 510(k) (Traditional)
- Applicant: Dr. Lee Co., Ltd.
- Decided: Aug 21, 1998 after 406 days
- Product code: LOS
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Dr.LEE ECG-310A (with interpretive software) is to be used to process the electrical signal transmitted through electrodes and to produce a visual display of the electrical signal produced by the heart. While the Dr.LEE ECG-310A is capable of interpreting the ECG waveform as an aid, it is not intended to replace the review and interpretation by the physician. To be used under professional healthcare supervision.

Source page: https://510kreport.com/device/K972587
Methodology: https://510kreport.com/methodology