K-number	K152126
Device name	UST-5550-R; UST-5536-R; L43K
Applicant	Hitachi Aloka Medical America, Inc.
Product code	ITX
Device class	Class II
Decision date	Aug 17, 2016
Decision	Substantially Equivalent
Regulation	892.1570

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View the full FDA submission: accessdata.fda.gov

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UST-5550-R; UST-5536-R; L43K

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