K-number	K131088
Device name	PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
Applicant	Sonoscape Company Limited
Product code	IYN
Device class	Class II
Decision date	May 24, 2013
Decision	Substantially Equivalent
Regulation	892.1550

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Source

View the full FDA submission: accessdata.fda.gov

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PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM

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