Bothealth BSX501
by Shenzhen BSX Technology Electronics Co., Ltd.
Bothealth BSX501 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 06920485305015), 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 | Number06920485305015 | Date14 Dec 2019 | StatusListed |
| United States | FDA 510(k) | NumberK183058 | Date3 Jul 2019 | StatusActive |
Official records
- AccessGUDID record 06920485305015
- FDA 510(k) database K183058
Across registries
- FDA 510(k) K183058 decided 3 Jul 2019 Active
- FDA GUDID UDI-DI 06920485305015 listed 14 Dec 2019 Listed
Timeline
- Cleared FDA 510(k) K183058
- Listed FDA GUDID 06920485305015
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- Withdrawn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
- BSX501
- Primary DI / UDI-DI
- 06920485305015
- 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
Similar devices in this category
Other devices filed under Patient monitoring system module, blood pressure, noninvasive.
Other devices from Shenzhen Bsx Technology Electronics Co., Ltd.
See all devices from Shenzhen Bsx Technology Electronics Co., Ltd. →