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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 K180375
Device Name The IQoolTM Warm System
Applicant
Brain Cool AB
Scheelevägen 2
Medicon Village,  SE SE-223 81
Applicant Contact Martin Waleij
Correspondent
Target Health Inc
261 Madison Ave
New York,  NY  10016
Correspondent Contact Adam Harris
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received02/12/2018
Decision Date 05/18/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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