Name: Predicase
Price: 199 USD

K-number	K163381
Device name	HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable
Applicant	Edwards Lifesciences, LLC
Product code	DQK
Device class	Class II
Decision date	Apr 14, 2017
Decision	Substantially Equivalent
Regulation	870.1425

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Source

View the full FDA submission: accessdata.fda.gov

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HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable

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