Name: Predicase
Price: 199 USD

K-number	K163054
Device name	DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System
Applicant	Osprey Medical, Inc.
Product code	DXT
Device class	Class II
Decision date	Mar 8, 2017
Decision	Substantially Equivalent
Regulation	870.1650

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Source

View the full FDA submission: accessdata.fda.gov

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DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System

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