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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 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.

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. 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.

Related Devices (Code: MUH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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