Biotres— 510(k) K211709

Substantially Equivalent

Biotricity

FDA 510(k) clearance K211709 for Biotres, Substantially Equivalent on 2022-01-19. Applicant: Biotricity.

Clearance details

Applicant: Biotricity
Product code: Code MWJ
Advisory panel: Cardiovascular
Date received: 2021-06-03
Decision date: 2022-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWJ

product code MWJ

Other: 1
Total: 1

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.