K-number	K173366
Device name	NicoletOne
Applicant	Natus Neurology Incorporated
Product code	OLZ
Device class	Class II
Decision date	Jul 20, 2018
Decision	Substantially Equivalent
Regulation	882.1400

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Source

View the full FDA submission: accessdata.fda.gov

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NicoletOne

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