FDA 510(k)

TuxDeluxe (Size 1 6100B, Size 2 6101B)

Número K: K232552 · 2023-10-20

Data da decisão2023-10-20

Código do produtoMUH

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

TuxDeluxe (Size 1 6100B, Size 2 6101B) is the device name listed in this FDA 510(k) record. The listed applicant is Tuxedo Imaging, LLC. It received FDA 510(k) clearance on 2023-10-20 under 510(k) number K232552. 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 TuxDeluxe (Size 1 6100B, Size 2 6101B)?

TuxDeluxe (Size 1 6100B, Size 2 6101B) is a medical device that received FDA 510(k) clearance on 2023-10-20. The listed applicant is Tuxedo Imaging, LLC. The 510(k) number is K232552.

When did TuxDeluxe (Size 1 6100B, Size 2 6101B) receive FDA 510(k) clearance?

TuxDeluxe (Size 1 6100B, Size 2 6101B) received FDA 510(k) clearance on 2023-10-20, under 510(k) number K232552.

Who is the listed applicant for TuxDeluxe (Size 1 6100B, Size 2 6101B)?

The FDA 510(k) record lists Tuxedo Imaging, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TuxDeluxe (Size 1 6100B, Size 2 6101B)?

The FDA product code for TuxDeluxe (Size 1 6100B, Size 2 6101B) is MUH.

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