Bothealth BSX515
by Shenzhen BSX Technology Electronics Co., Ltd.
Bothealth BSX515 is a Class II device made by Shenzhen BSX Technology Electronics Co., Ltd., cleared under FDA 510(k) K183058 on 3 Jul 2019 and listed in FDA GUDID since 14 Dec 2019 (UDI-DI 06920485305152), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number06920485305152 | Date14 Dec 2019 | StatusListed |
| United States | FDA 510(k) | NumberK183058 | Date3 Jul 2019 | StatusActive |
Official records
- AccessGUDID record 06920485305152
- FDA 510(k) database K183058
Across registries
- FDA 510(k) K183058 decided 3 Jul 2019 Active
- FDA GUDID UDI-DI 06920485305152 listed 14 Dec 2019 Listed
Timeline
- Cleared FDA 510(k) K183058
- Listed FDA GUDID 06920485305152
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Bothealth
- Generic name
- Patient monitoring system module, blood pressure, noninvasive
- Model / reference
- BSX515
- Primary DI / UDI-DI
- 06920485305152
- 510(k) Number
- FDA product code
- DXN
- GMDN term
- Patient monitoring system module, blood pressure, noninvasive
- Device class
- Class II
- Regulation number
- 870.1130
- GUDID distribution status
- In Commercial Distribution
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