Name: Predicase
Price: 199 USD

K-number	K040050
Device name	INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500
Applicant	Ge Medical Systems Navigation and Visualization IN
Product code	LLZ
Device class	Class II
Decision date	Mar 24, 2004
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500

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