Bioflux Software II
by Biotricity
510(k) K201040
Bioflux Software II is a Class II device made by Biotricity, cleared under FDA 510(k) K201040 on 29 Jul 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 | NumberK201040 | Date29 Jul 2020 | StatusActive |
Official records
- FDA 510(k) database K201040
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DSH
- Device class
- Class II
- Regulation
- 21 CFR Part 870.2800
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
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