Bioflux Software
510(k) K162571
Bioflux Software is a Class II device made by Biotricity, Inc., cleared under FDA 510(k) K162571 on 13 Oct 2016, 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 | NumberK162571 | Date13 Oct 2016 | StatusActive |
Official records
- FDA 510(k) database K162571
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- Withdrawn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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