K-number	K232552
Device name	TuxDeluxe (Size 1 6100B, Size 2 6101B)
Applicant	Tuxedo Imaging, LLC
Product code	MUH
Device class	Class II
Decision date	Oct 20, 2023
Decision	Substantially Equivalent
Regulation	872.1800

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View the full FDA submission: accessdata.fda.gov

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

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