K-number	K222794
Device name	FlowStar Touch Digital Mixer Flowmeter
Applicant	Baldus Sedation GmbH & Co. KG
Product code	BZR
Device class	Class II
Decision date	Jul 28, 2023
Decision	Substantially Equivalent
Regulation	868.5330

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Source

View the full FDA submission: accessdata.fda.gov

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FlowStar Touch Digital Mixer Flowmeter

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