Data / Medical devices / China / Beijing Bywave Sensing Medical Technology Co., Ltd.
Beijing Bywave Sensing Medical Technology Co., Ltd.: FDA-registered device maker in Beijing, China, 1 510(k) clearance
Beijing Bywave Sensing Medical Technology Co., Ltd. is registered with the FDA (registration 3018784828) in Beijing, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 18, 2021. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3018784828
- Address
- Room 301, 1st to 3rd Floor, Building 33, Yard 6, Hengye 7th Street, Tongzhou District Beijing, P. R. China, Beijing, China, 100086
- Owner or operator
- BEIJING BYWAVE SENSING MEDICAL TECHNOLOGY CO., LTD. (10081193)
- Roles
- Manufacturer
- First device listed
- March 29, 2021
- Registered through
- 2026
- Brand names listed
- LiPPS Intravascular Pressure Sensing System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Transducer, Pressure, Catheter Tip | DXO | 2 | Manufacturer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 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 18, 2021 | K201720 | LiPPS Analyzer, LiPPS Wire Pressure Guide Wire | DQX | Substantially Equivalent | Beijing Bywave Sensing Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated February 18, 2021. 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.