K-number	K151433
Device name	AUDICOR CA300/CC100 Analyzer with SDB
Applicant	Inovise Medical, Inc.
Product code	MNR
Device class	Class II
Decision date	Mar 18, 2016
Decision	Substantially Equivalent
Regulation	868.2375

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Source

View the full FDA submission: accessdata.fda.gov

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AUDICOR CA300/CC100 Analyzer with SDB

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