FDA 510(k)

Cocoon Convective Warming System, Model CWS7000

Número K: K232502 · 2024-02-21

Data da decisão2024-02-21

Código do produtoDWJ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is Care Essentials Pty, Ltd.. The 510(k) number is K232502.

When did Cocoon Convective Warming System, Model CWS7000 receive FDA 510(k) clearance?

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

Who is the listed applicant for Cocoon Convective Warming System, Model CWS7000?

The FDA 510(k) record lists Care Essentials Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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Fonte oficial

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