B-Secur HeartKey Software Library— 510(k) K200884

Substantially Equivalent

B-Secur , Ltd.

FDA 510(k) clearance K200884 for B-Secur HeartKey Software Library, Substantially Equivalent on 2020-12-07. Applicant: B-Secur , Ltd..

Clearance details

Applicant: B-Secur , Ltd.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2020-04-02
Decision date: 2020-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Belfast, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.