FDA 510(k)

Cocoon Portable Handheld X-Ray System

Número K: K173046 · 2017-10-26

Data da decisão2017-10-26

Código do produtoMUH

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Cocoon Portable Handheld X-Ray System is the device name listed in this FDA 510(k) record. The listed applicant is Dexcowin Co., Ltd.. It received FDA 510(k) clearance on 2017-10-26 under 510(k) number K173046. 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 Portable Handheld X-Ray System?

Cocoon Portable Handheld X-Ray System is a medical device that received FDA 510(k) clearance on 2017-10-26. The listed applicant is Dexcowin Co., Ltd.. The 510(k) number is K173046.

When did Cocoon Portable Handheld X-Ray System receive FDA 510(k) clearance?

Cocoon Portable Handheld X-Ray System received FDA 510(k) clearance on 2017-10-26, under 510(k) number K173046.

Who is the listed applicant for Cocoon Portable Handheld X-Ray System?

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

What is the FDA product code for Cocoon Portable Handheld X-Ray System?

The FDA product code for Cocoon Portable Handheld X-Ray System is MUH.

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Dispositivos Relacionados (Código: MUH)

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