# Shenzhen Biocare Bio-Medical Equipment Co., Ltd.

- Location (FDA's records): Shanghai, CN
- FDA decisions: 5 (2014–2016): 5 510(k) clearances
- Product codes: DPS (5)
- Predicates its devices cite: 8 (2 its own); citations of its devices by later devices: 5 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Edan Instruments, Inc.: 3 (https://510kreport.com/company/edan-instruments)
- Shenzhen Biocare Electronics Co., Ltd.: 2 (https://510kreport.com/company/shenzhen-biocare-electronics)
- Heartlab, Inc.: 1 (https://510kreport.com/company/heartlab)

## Firms that cite its devices most
- Mediblu Medical, LLC: 2 (https://510kreport.com/company/mediblu-medical)
- Biocare Bio-Medical Equipment Co., Ltd.: 1 (https://510kreport.com/company/biocare-bio-medical-equipment)

## Its most-cited devices
- K141946: Digital Electrocardiograph (2015), cited by 2
- K160092: Digital Electrocardiograph (2016), cited by 1
- K132758: Digital Electrocardiograph (2014), cited by 1
- K133985: Digital Electrocardiograph (2015), cited by 1

## Recent decisions
- K160092: Digital Electrocardiograph (Feb 12, 2016)
- K152384: Digital Electrocardiograph (Dec 18, 2015)
- K141946: Digital Electrocardiograph (Feb 13, 2015)
- K133985: Digital Electrocardiograph (Jan 22, 2015)
- K132758: Digital Electrocardiograph (Jan 30, 2014)

Source page: https://510kreport.com/company/shenzhen-biocare-bio-medical-equipment