K-number	K212021
Device name	6430 MyLabX75, 6430 MyLab XPro75
Applicant	Esaote, S.p.A.
Product code	IYN
Device class	Class II
Decision date	Sep 16, 2021
Decision	Substantially Equivalent
Regulation	892.1550

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View the full FDA submission: accessdata.fda.gov

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6430 MyLabX75, 6430 MyLab XPro75

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