Name: Predicase
Price: 199 USD

K-number	K101868
Device name	INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V
Applicant	Toshiba America Medical Systems, In.C
Product code	OWB
Device class	Class II
Decision date	Sep 7, 2010
Decision	Substantially Equivalent
Regulation	892.1650

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Source

View the full FDA submission: accessdata.fda.gov

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INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V

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