Bright High Flow
510(k) K200155
Bright High Flow is a Class II device made by GENOSS CO., Ltd., cleared under FDA 510(k) K200155 on 30 Nov 2020, 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 | FDA 510(k)SESE | NumberK200155 | Date30 Nov 2020 | StatusActive |
Official records
- FDA 510(k) database K200155
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EBF
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3690
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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