510(k) K232502— Cocoon Convective Warming System, Model CWS7000

Substantially Equivalent

Care Essentials Pty, Ltd.

Clearance details

Applicant: Care Essentials Pty, Ltd.
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 2023-08-18
Decision date: 2024-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Geelong, AU

Adverse events under product code DWJ

product code DWJ

Death: 7
Injury: 679
Malfunction: 17,477
Total: 18,163

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.