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FDA 510(k)

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

K-Number: K232552 · 2023-10-20

ApplicantTuxedo Imaging, LLC
Decision Date2023-10-20
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TuxDeluxe (Size 1 6100B, Size 2 6101B) is a medical device manufactured by Tuxedo Imaging, LLC. It received FDA 510(k) clearance on 2023-10-20 under approval number K232552. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Tuxedo Imaging, LLC. The 510(k) number is K232552.

When was TuxDeluxe (Size 1 6100B, Size 2 6101B) approved by the FDA?

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

What company makes TuxDeluxe (Size 1 6100B, Size 2 6101B)?

TuxDeluxe (Size 1 6100B, Size 2 6101B) is manufactured by Tuxedo Imaging, LLC.

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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