K-number	K163138
Device name	Clarius Ultrasound System
Applicant	Clarius Mobile Health Corp.
Product code	IYN
Device class	Class II
Decision date	Nov 30, 2016
Decision	Substantially Equivalent
Regulation	892.1550

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Source

View the full FDA submission: accessdata.fda.gov

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Clarius Ultrasound System

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