Cocoon Convective Warming System— 510(k) K181671

Name: FDA 510(k) clearance K181671
Creator: U.S. Food and Drug Administration
Published: 2019-05-02

Substantially Equivalent

Care Essentials Pty, Ltd.

FDA 510(k) clearance K181671 for Cocoon Convective Warming System, Substantially Equivalent on 2019-05-02. Applicant: Care Essentials Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Care Essentials Pty, Ltd.
Product code: Code DWJ
Device class: Class 2
Regulation: 21 CFR 870.5900
Advisory panel: Cardiovascular
Date received: 2018-06-25
Decision date: 2019-05-02
Decision: Substantially Equivalent
Clearance type: Special
Location: North Geelong, AU

Download summary PDF View on FDA.gov ↗

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More clearances from Care Essentials Pty, Ltd.

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K232502 — Cocoon Convective Warming System, Model CWS70002024-02-21
K213907 — CareGUARD Sterilization Wrap2022-03-14
K140635 — COCOON CONVECTIVE WARMING SYSTEM2014-07-25

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.