# K120188: Electrocardiograph

- Pathway: 510(k) (Special)
- Applicant: Edan Instruments, Inc.
- Decided: Mar 16, 2012 after 53 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
Longest line of descent: 4 generations back to K921669 (1993). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014108: Mac 5000 Ecg Analysis System, General Electric Medical Systems Information Techn (2002) Summary page 1.

## Indications for use
The intended use of SE-1201 12-channel electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare and professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG wit measurements and interpretive statements is offered to clinicians on an advisory basis only.

Source page: https://510kreport.com/device/K120188
Methodology: https://510kreport.com/methodology