FDA 510(k)

8X-10-6XXX Cabeça de Câmera

Número K: K223116 · 2023-02-28

Data da decisão2023-02-28

Código do produtoGCJ

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

8X-10-6XXX Camera Head is the device name listed in this FDA 510(k) record. The listed applicant is Santa Barbara Imaging Systems. It received FDA 510(k) clearance on 2023-02-28 under 510(k) number K223116. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the 8X-10-6XXX Camera Head?

8X-10-6XXX Camera Head is a medical device that received FDA 510(k) clearance on 2023-02-28. The listed applicant is Santa Barbara Imaging Systems. The 510(k) number is K223116.

When did 8X-10-6XXX Camera Head receive FDA 510(k) clearance?

8X-10-6XXX Camera Head received FDA 510(k) clearance on 2023-02-28, under 510(k) number K223116.

Who is the listed applicant for 8X-10-6XXX Camera Head?

The FDA 510(k) record lists Santa Barbara Imaging Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 8X-10-6XXX Camera Head?

The FDA product code for 8X-10-6XXX Camera Head is GCJ.

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