K-number	K061994
Device name	WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE
Applicant	GE Healthcare
Product code	MSX
Device class	Class II
Decision date	Aug 11, 2006
Decision	Substantially Equivalent
Regulation	870.2300

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Source

View the full FDA submission: accessdata.fda.gov

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WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE

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