K-number	K120629
Device name	FDR GO FLEX
Applicant	Fujifilm Medical System U.S.A., Inc.
Product code	MQB
Device class	Class II
Decision date	Aug 28, 2012
Decision	Substantially Equivalent
Regulation	892.1680

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Source

View the full FDA submission: accessdata.fda.gov

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FDR GO FLEX

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