K-number	K190497
Device name	Ziehm 8000
Applicant	Ziehm Imaging GmbH
Product code	OWB
Device class	Class II
Decision date	Nov 20, 2019
Decision	Substantially Equivalent
Regulation	892.1650

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Source

View the full FDA submission: accessdata.fda.gov

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Ziehm 8000

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