K-number	K170832
Device name	Ultimax-i, DREX-UI80 V1.60
Applicant	Toshibamedical Systems Corporation
Product code	OWB
Device class	Class II
Decision date	Jul 21, 2017
Decision	Substantially Equivalent
Regulation	892.1650

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View the full FDA submission: accessdata.fda.gov

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Ultimax-i, DREX-UI80 V1.60

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