FDA 510(k)

DCX Disposable Cassette (DCX)

Número K: K243998 · 2025-04-25

Data da decisão2025-04-25

Código do produtoKDN

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

DCX Disposable Cassette (DCX) is the device name listed in this FDA 510(k) record. The listed applicant is Institut Geroges Lopez. It received FDA 510(k) clearance on 2025-04-25 under 510(k) number K243998. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DCX Disposable Cassette (DCX)?

DCX Disposable Cassette (DCX) is a medical device that received FDA 510(k) clearance on 2025-04-25. The listed applicant is Institut Geroges Lopez. The 510(k) number is K243998.

When did DCX Disposable Cassette (DCX) receive FDA 510(k) clearance?

DCX Disposable Cassette (DCX) received FDA 510(k) clearance on 2025-04-25, under 510(k) number K243998.

Who is the listed applicant for DCX Disposable Cassette (DCX)?

The FDA 510(k) record lists Institut Geroges Lopez as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DCX Disposable Cassette (DCX)?

The FDA product code for DCX Disposable Cassette (DCX) is KDN.

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