K-number	K141063
Device name	LINSCAN 808, LINSCAN 980
Applicant	Gme (German Medical Engineering) GmbH
Product code	GEX
Device class	Class II
Decision date	Jul 15, 2014
Decision	Substantially Equivalent
Regulation	878.4810

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View the full FDA submission: accessdata.fda.gov

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LINSCAN 808, LINSCAN 980

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