# K133985: Digital Electrocardiograph

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
- Decided: Jan 22, 2015 after 392 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). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092010: PC Ecg, Model SE-1010, Edan Instruments, Inc. (2009) Summary page 5.
- K123816: Digital Electrocardiographs, Shenzhen Biocare Electronics Co., Ltd. (2013) Summary page 5.

## Most influential descendants
- K152384: Digital Electrocardiograph (2015), 0 descendants of its own

## Indications for use
Digital Electrocardiograph is intended to acquire ECG signals from adult patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiograph shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

Source page: https://510kreport.com/device/K133985
Methodology: https://510kreport.com/methodology