# K131262: Digital Electrocardiographs

- Pathway: 510(k) (Traditional)
- Applicant: Sonoscape Company Limited
- Decided: Nov 14, 2013 after 195 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). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122712: Digital Electrocardiograph, Shenzhen Biocare Electronics Co., Ltd. (2012) Summary page 2.
- K123816: Digital Electrocardiographs, Shenzhen Biocare Electronics Co., Ltd. (2013) Summary page 2.

## Indications for use
Digital Electrocardiographs, 1E3/ lE6/IE12/ IEI2P/ I1315, are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECO records can help users to analyze and diagnose beant disease. Digital Electrocardiogyaphs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

Source page: https://510kreport.com/device/K131262
Methodology: https://510kreport.com/methodology