Data / Medical devices / China / Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
Shenzhen Biocare Bio-Medical Equipment Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 4 510(k) clearances
Shenzhen Biocare Bio-Medical Equipment Co., Ltd. is registered with the FDA (registration 3008457078) in Shenzhen Guangdong, China. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 11, 2018. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008457078
- Address
- #16-1, Jinhui Road, Jinsha Community Kengzi Sub-District, Pingshan New District, Shenzhen Guangdong, China, 518122
- Owner or operator
- Shenzhen Biocare Bio-Medical Equipment Co., LTD (10036523)
- Roles
- Manufacturer
- First device listed
- May 13, 2011
- Registered through
- 2027
- Brand names listed
- Digital Electrocardiograph iE 101 and iE300, Digital Electrocardiograph iE 10, Digital electrocardiograph, FM-200 Doppler Fetal Heart Rate Detector, iE 3, iE 6, iE 12, iE 12A, iE 15, ECG-12l0, ECG-3010 and ECG-6010
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrocardiograph | DPS | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Ultrasonic, Fetal | KNG | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 11, 2018 | K171517 | Digital Electrocardiograph | DPS | Substantially Equivalent | Biocare Bio-Medical Equipment Co., Ltd. | accessdata.fda.gov |
| February 12, 2016 | K160092 | Digital Electrocardiograph | DPS | Substantially Equivalent | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | accessdata.fda.gov |
| February 13, 2015 | K141946 | DIGITAL ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | accessdata.fda.gov |
| May 21, 2010 | K100626 | DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200 | KNG | Substantially Equivalent | Shenzhen Biocare Electronics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated January 11, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.