K-number	K033964
Device name	SOLAR 9500 INFORMATION MONITOR
Applicant	Ge Medical Systems Information Technologies
Product code	MHX
Device class	Class II
Decision date	Jan 15, 2004
Decision	Substantially Equivalent
Regulation	870.1025

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Source

View the full FDA submission: accessdata.fda.gov

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SOLAR 9500 INFORMATION MONITOR

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