Name: Predicase
Price: 199 USD

K-number	K073462
Device name	MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES
Applicant	Ge Medical Systems Information Technologies
Product code	MHX
Device class	Class II
Decision date	Jan 11, 2008
Decision	Substantially Equivalent
Regulation	870.1025

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Source

View the full FDA submission: accessdata.fda.gov

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MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES

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