K-number	K183599
Device name	Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter
Applicant	Infraredx, Inc.
Product code	OGZ
Device class	Class II
Decision date	Apr 12, 2019
Decision	Substantially Equivalent
Regulation	870.1200

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Source

View the full FDA submission: accessdata.fda.gov

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Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter

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