Name: Predicase
Price: 199 USD

K-number	K130169
Device name	FMS VUE FLUID MANAGMENT SYSTEM, FMS CONNECT INTERFACE CABLE
Applicant	Depuy Mitek, A Johnson & Johnson Company
Product code	HRX
Device class	Class II
Decision date	May 1, 2013
Decision	Substantially Equivalent
Regulation	888.1100

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Source

View the full FDA submission: accessdata.fda.gov

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FMS VUE FLUID MANAGMENT SYSTEM, FMS CONNECT INTERFACE CABLE

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