K-number	K192440
Device name	FDR SE Lite
Applicant	Fujifilm Corporation
Product code	MQB
Device class	Class II
Decision date	Nov 1, 2019
Decision	Substantially Equivalent
Regulation	892.1680

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Source

View the full FDA submission: accessdata.fda.gov

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FDR SE Lite

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