K-number	K990068
Device name	SOLAR 9500 INFORMATION MONITOR
Applicant	General Electric Medical Systems Information Techn
Product code	MHX
Device class	Class II
Decision date	Jul 14, 1999
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.