K-number	K914302
Device name	GEN-X 800/650
Applicant	Swissray Finatech, Inc.
Product code	IZO
Device class	Class I
Decision date	Oct 30, 1991
Decision	Substantially Equivalent
Regulation	892.1700

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View the full FDA submission: accessdata.fda.gov

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GEN-X 800/650

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