K-number	K232844
Device name	The IQoolTM System
Applicant	Braincool AB
Product code	DWJ
Device class	Class II
Decision date	Oct 4, 2023
Decision	Substantially Equivalent
Regulation	870.5900

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Source

View the full FDA submission: accessdata.fda.gov

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The IQoolTM System

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