# K090936: Single-Channel Handheld Electrocardiograph, Model ECG80A

- Pathway: 510(k) (Traditional)
- Applicant: Contec Medical System Co., Ltd.
- Decided: Aug 25, 2009 after 145 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: 3 generations back to K002074 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082124: Carditte Microtel, Et Medical Devices Spa (2009) Summary page 1.
- K051534: Cardioline AR 600, AR 1200, AR 2100, Et Medical Devices Spa (2005) Summary page 1.

## Indications for use
The ECG80A Single-Channel Handheld Electrocardiograph is intended for use in non-invasive recording and displaying ECG waveform of adult patients. In addition, it also can provide to the treating physician with relevant data on the cardiac rhythm in hospital patients. It is immediately available at any time to manually record transient cardiac events, suitable for patient and professional use, helpful in determining the cardiac rhythm at the time of symptoms. This device allows the patient to record their ECG data for displaying or print on the paper. The product is not a conventional diagnostic tool.

Source page: https://510kreport.com/device/K090936
Methodology: https://510kreport.com/methodology