K192584

Substantially Equivalent

BEACON Caresystem Model 00002144

Applicant: Mermaid Care A/S
Product code: BZK
Advisory panel: Anesthesiology
Date received: 2019-09-19
Decision date: 2019-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norresundby, DK

Adverse events under product code BZK

product code BZK

Death: 2
Total: 2

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.