K-number	K844428
Device name	RADIOTOM 804
Applicant	Siemens Medical Solutions USA, Inc.
Product code	GEI
Device class	Class II
Decision date	Feb 20, 1985
Decision	Substantially Equivalent
Regulation	—

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View the full FDA submission: accessdata.fda.gov

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RADIOTOM 804

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