K-number	K223902
Device name	FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)
Applicant	Echosens
Product code	IYO
Device class	Class II
Decision date	Mar 2, 2023
Decision	Substantially Equivalent
Regulation	892.1560

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Source

View the full FDA submission: accessdata.fda.gov

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FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)

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