# K171360: CONTEC™ Electrocardiograph

- Pathway: 510(k) (Traditional)
- Applicant: Contec Medical Systems Co.,Ltd
- Decided: Jan 22, 2018 after 258 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: 9 generations back to K921669 (1993). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131900: Contec Electrocardiograph, Contec Medical System Co., Ltd. (2014) Summary page 7.

## Indications for use
CONTECTM Electrocardiograph, ECG90A, is intended to acquire ECG signals from adult or children patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. The proposed devices also have measurements and diagnostic interpretation functions, which are offered to clinician on an advisory basis. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

Source page: https://510kreport.com/device/K171360
Methodology: https://510kreport.com/methodology