BEACON Caresystem Model 00002144— 510(k) K192584

Substantially Equivalent

Mermaid Care A/S

FDA 510(k) clearance K192584 for BEACON Caresystem Model 00002144, Substantially Equivalent on 2019-12-18. Applicant: Mermaid Care A/S.

Clearance details

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

Download summary PDF View on FDA.gov ↗

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.