# K972603: Electrocardiographs Models 110B, 120B and 310B

- Pathway: 510(k) (Traditional)
- Applicant: Dr. Lee Co., Ltd.
- Decided: Mar 11, 1998 after 243 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- 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-110B, 120B and 310B (non-interpretive electrocardiographs) is used to process the electrical signal transmitted through electrocardiograph electrodes to produce a visual display of the electrical signhal produced by the heart. The patient population is any patient requiring an electrocardiograph at the direction of a physician. The product is to be used in a medical professional environment, such as a doctors office, hospital, medical clinic and the like.

Source page: https://510kreport.com/device/K972603
Methodology: https://510kreport.com/methodology