Name: Predicase
Price: 199 USD

K-number	K092079
Device name	MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND
Applicant	Ge Medical Systems Israel, Ultrasound, Ltd.
Product code	IYN
Device class	Class II
Decision date	Aug 6, 2009
Decision	Substantially Equivalent
Regulation	892.1550

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Source

View the full FDA submission: accessdata.fda.gov

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MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND

Everything you need for a 510(k) submission. Nothing you don't.