Bioflux Software II— 510(k) K201040

Substantially Equivalent

Biotricity

FDA 510(k) clearance K201040 for Bioflux Software II, Substantially Equivalent on 2020-07-29. Applicant: Biotricity.

Clearance details

Applicant: Biotricity
Product code: Code DSH
Advisory panel: Cardiovascular
Date received: 2020-04-01
Decision date: 2020-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSH

product code DSH

Death: 3
Injury: 652
Total: 655

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.