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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
Braincool 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
Predetermined Change
Control Plan Authorized		 No
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