Name: Predicase
Price: 199 USD

K-number	K081121
Device name	MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM
Applicant	Siemens Medical Solutions USA, Inc., Ultrasound DI
Product code	IYO
Device class	Class II
Decision date	Jun 4, 2008
Decision	Substantially Equivalent
Regulation	892.1560

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Source

View the full FDA submission: accessdata.fda.gov

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MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM

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