# K972996: Easy Ecg PC Based Electrocardiograph

- Pathway: 510(k) (Traditional)
- Applicant: Ates Medical S.R.L.
- Decided: Apr 28, 1998 after 259 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
Easy ECG is designed and used for recording and visualizing the ECG tracing through personal computers. It is consisting of intelligent modules which can be connected to a PC’s serial port and software for display and printing of ECG tracing on any laser or inkjet printer. East ECG acquired simultaneously 12 leads for 4/8 seconds and then display the tracing on the monitor’s screen. The advantage of PC Based EAST ECG is enabling physicians and cardiologists to use it with existing computers.

Source page: https://510kreport.com/device/K972996
Methodology: https://510kreport.com/methodology