K-number	K162523
Device name	The IQool System
Applicant	Braincool AB
Product code	NZE
Device class	Class II
Decision date	May 3, 2017
Decision	Substantially Equivalent
Regulation	870.5900

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Source

View the full FDA submission: accessdata.fda.gov

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The IQool System

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