Name: Predicase
Price: 199 USD

K-number	K152582
Device name	CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box
Applicant	Volcano Corporation
Product code	DSK
Device class	Class II
Decision date	Dec 3, 2015
Decision	Substantially Equivalent
Regulation	870.1110

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box

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