Data / Medical devices / China / Shenzhen BSX Technology Electronics Co.,ltd
Shenzhen BSX Technology Electronics Co.,ltd: FDA-registered device maker in Shen Zhen Guangdong, China, 5 510(k) clearances
Shenzhen BSX Technology Electronics Co.,ltd is registered with the FDA (registration 3015542362) in Shen Zhen Guangdong, China. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated February 19, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015542362
- Address
- Rm101&2/F~4/F, Building No.13, Ailian Industrial park, Wulian Community, Longgang District, Shenzhen, Shen Zhen Guangdong, China, 518116
- Owner or operator
- Shenzhen BSX Technology Electronics Co.,Ltd (10060909)
- Roles
- Manufacturer
- First device listed
- July 11, 2019
- Registered through
- 2026
- Brand names listed
- Arm-Type Electronic Blood Pressure Monitor Moderl BSX5011, Arm-Type Electronic Blood Pressure Monitor Moderl BSX5021, Arm-Type Electronic Blood Pressure Monitor Moderl BSX5035, Arm-Type Electronic Blood Pressure Monitor Moderl BSX505, Arm-Type Electronic Blood Pressure Monitor Moderl BSX5113, Arm-Type Electronic Blood Pressure Monitor Moderl BSX5125, Arm-Type Electronic Blood Pressure Monitor Moderl BSX513, Arm-Type Electronic Blood Pressure Monitor Moderl BSX515 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Light Based Over-The-Counter Hair Removal | OHT | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter, Infrared, Sporting, Aviation | OCH | 2 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 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 |
|---|---|---|---|---|---|---|
| February 19, 2025 | K241578 | Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355) | DXN | Substantially Equivalent | Shenzhen Bsx Technology Electronics Co., Ltd. | accessdata.fda.gov |
| April 6, 2023 | K230097 | IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108 | OHT | Substantially Equivalent | Shenzhen Bsx Technology Electronics Co., Ltd. | accessdata.fda.gov |
| July 23, 2021 | K202296 | Infrared Forehead Thermometer, Model BSX976 | FLL | Substantially Equivalent | Shenzhen Bsx Technology Electronics Co., Ltd. | accessdata.fda.gov |
| December 14, 2020 | K202324 | Fingertip Pulse Oximeter | DQA | Substantially Equivalent | Shenzhen Bsx Technology Electronics Co., Ltd. | accessdata.fda.gov |
| July 3, 2019 | K183058 | Arm-type Electronic Blood Pressure Monitor | DXN | Substantially Equivalent | Shenzhen Bsx Technology Electronics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Oximeter, Infrared, Sporting, Aviation
- All makers of Light Based Over-The-Counter Hair Removal
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Oximeter
- All makers of Continuous Measurement Thermometer
Updated February 19, 2025. 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.