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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Thermal Regulating
510(k) Number K232844
Device Name The IQoolTM System
Applicant
Braincool AB
Medicon Village Scheelevagen 2
Lund,  SE 223 81
Applicant Contact Martin Waleij
Correspondent
Target Health, LLC
450 Commerce Blvd.
Carlstadt,  NJ  07072
Correspondent Contact Adam Harris
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received09/14/2023
Decision Date 10/04/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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