K-number	K193410
Device name	SOZO Body Fluid Analyzer
Applicant	ImpediMed Limited
Product code	DSB
Device class	Class II
Decision date	Oct 2, 2020
Decision	Substantially Equivalent
Regulation	870.2770

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Source

View the full FDA submission: accessdata.fda.gov

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SOZO Body Fluid Analyzer

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