K-number	K180375
Device name	The IQoolTM Warm System
Applicant	Braincool AB
Product code	DWJ
Device class	Class II
Decision date	May 18, 2018
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 Warm System

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