FDA 510(k)

Cocoon Convective Warming System, Model CWS7000

K-Number: K232502 · 2024-02-21

Decision Date2024-02-21

Product CodeDWJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Cocoon Convective Warming System, Model CWS7000 is a medical device manufactured by Care Essentials Pty, Ltd.. It received FDA 510(k) clearance on 2024-02-21 under approval number K232502. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cocoon Convective Warming System, Model CWS7000?

Cocoon Convective Warming System, Model CWS7000 is a medical device that received FDA 510(k) clearance on 2024-02-21. It is manufactured by Care Essentials Pty, Ltd.. The 510(k) number is K232502.

When was Cocoon Convective Warming System, Model CWS7000 approved by the FDA?

Cocoon Convective Warming System, Model CWS7000 received FDA 510(k) clearance on 2024-02-21, under approval number K232502.

What company makes Cocoon Convective Warming System, Model CWS7000?

Cocoon Convective Warming System, Model CWS7000 is manufactured by Care Essentials Pty, Ltd..

What is the FDA product code for Cocoon Convective Warming System, Model CWS7000?

The FDA product code for Cocoon Convective Warming System, Model CWS7000 is DWJ.

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Other Devices by Care Essentials Pty, Ltd.

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Related Devices (Code: DWJ)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.