FDA 510(k)

Cocoon Solo (DX-7020s)

Número K: K250687 · 2025-10-24

Data da decisão2025-10-24

Código do produtoMUH

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Cocoon Solo (DX-7020s) is the device name listed in this FDA 510(k) record. The listed applicant is Dexcowin Global, Inc.. It received FDA 510(k) clearance on 2025-10-24 under 510(k) number K250687. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Cocoon Solo (DX-7020s)?

Cocoon Solo (DX-7020s) is a medical device that received FDA 510(k) clearance on 2025-10-24. The listed applicant is Dexcowin Global, Inc.. The 510(k) number is K250687.

When did Cocoon Solo (DX-7020s) receive FDA 510(k) clearance?

Cocoon Solo (DX-7020s) received FDA 510(k) clearance on 2025-10-24, under 510(k) number K250687.

Who is the listed applicant for Cocoon Solo (DX-7020s)?

The FDA 510(k) record lists Dexcowin Global, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cocoon Solo (DX-7020s)?

The FDA product code for Cocoon Solo (DX-7020s) is MUH.

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