Bionso PC828
by Shenzhen Pacom Medical Instruments Co., Ltd.
Bionso PC828 is a Class II device made by Shenzhen Pacom Medical Instruments Co., Ltd., cleared under FDA 510(k) K172889 on 25 May 2018 and listed in FDA GUDID since 1 May 2021 (UDI-DI 00840061482830), active as of 23 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 | Number00840061482830 | Date1 May 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK172889 | Date25 May 2018 | StatusActive |
Official records
- AccessGUDID record 00840061482830
- FDA 510(k) database K172889
Across registries
- FDA 510(k) K172889 decided 25 May 2018 Active
- FDA GUDID UDI-DI 00840061482830 listed 1 May 2021 Listed
Timeline
- Cleared FDA 510(k) K172889
- Listed FDA GUDID 00840061482830
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Bionso
- Generic name
- Infrared patient thermometer, skin
- Model / reference
- PC828
- Description
- Model: PC828; Brand: Bionso; One package box contains 50 instruments.
- Primary DI / UDI-DI
- 00840061482830
- 510(k) Number
- FDA product code
- FLL
- GMDN term
- Infrared patient thermometer, skin
- Device class
- Class II
- Regulation number
- 880.2910
- GUDID distribution status
- In Commercial Distribution
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