Name: Predicase
Price: 199 USD

K-number	K153193
Device name	Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)
Applicant	Zyno Medical, LLC
Product code	FRN
Device class	Class II
Decision date	Aug 30, 2016
Decision	Substantially Equivalent
Regulation	880.5725

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Source

View the full FDA submission: accessdata.fda.gov

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Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)

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