Name: Predicase
Price: 199 USD

K-number	K061163
Device name	INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT
Applicant	Ge Medical Systems, LLC
Product code	OWB
Device class	Class II
Decision date	Jun 7, 2006
Decision	Substantially Equivalent
Regulation	892.1650

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Source

View the full FDA submission: accessdata.fda.gov

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INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT

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