Name: Predicase
Price: 199 USD

K-number	K131382
Device name	EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL
Applicant	Invivo Corporation
Product code	MWI
Device class	Class II
Decision date	Jul 15, 2013
Decision	Substantially Equivalent
Regulation	870.2300

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL

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