FDA 510(k)

WARD-CSS (v1.2.x)

Número K: K241958 · 2025-02-14

Data da decisão2025-02-14

Código do produtoMWI

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

WARD-CSS (v1.2.x) is the device name listed in this FDA 510(k) record. The listed applicant is Ward 24/7 Aps. It received FDA 510(k) clearance on 2025-02-14 under 510(k) number K241958. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the WARD-CSS (v1.2.x)?

WARD-CSS (v1.2.x) is a medical device that received FDA 510(k) clearance on 2025-02-14. The listed applicant is Ward 24/7 Aps. The 510(k) number is K241958.

When did WARD-CSS (v1.2.x) receive FDA 510(k) clearance?

WARD-CSS (v1.2.x) received FDA 510(k) clearance on 2025-02-14, under 510(k) number K241958.

Who is the listed applicant for WARD-CSS (v1.2.x)?

The FDA 510(k) record lists Ward 24/7 Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WARD-CSS (v1.2.x)?

The FDA product code for WARD-CSS (v1.2.x) is MWI.

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Fonte oficial

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