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FDA 510(k) Applications Submitted by Martin Waleij
FDA 510(k) Number
Submission Date
Device Name
Applicant
K180375
02/12/2018
The IQoolTM Warm System
Brain Cool AB
DEN210027
07/02/2021
The Cooral System
BrainCool AB
K162523
09/09/2016
The IQool System
BRAIN COOL AB
K232844
09/14/2023
The IQoolTM System
BrainCool AB
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