FDA applicant
Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
FDA records 5 decisions for Shenzhen Biocare Bio-Medical Equipment Co., Ltd. (Shanghai, CN) from 2014 to 2016: 5 510(k) clearances. All are in product code DPS (Electrocardiograph). Its devices cite 8 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Shenzhen Biocare Bio-Medical Equipment Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2016
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2014.
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