K-number	K191747
Device name	FUJIFILM Duodenoscope Model ED-580XT
Applicant	Fujifilm Corporation
Product code	FDT
Device class	Class II
Decision date	Sep 27, 2019
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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FUJIFILM Duodenoscope Model ED-580XT

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