K-number	K143601
Device name	U-Lite
Applicant	Sonoscanner Sarl
Product code	IYN
Device class	Class II
Decision date	Mar 18, 2015
Decision	Substantially Equivalent
Regulation	892.1550

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Source

View the full FDA submission: accessdata.fda.gov

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U-Lite

Everything you need for a 510(k) submission. Nothing you don't.