K-number	K162329
Device name	CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System
Applicant	Philips Health Care
Product code	IYN
Device class	Class II
Decision date	Sep 14, 2016
Decision	Substantially Equivalent
Regulation	892.1550

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View the full FDA submission: accessdata.fda.gov

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CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System

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