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Braincool AB
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
4
Inspections
0
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K232844
The IQoolTM System
October 4, 2023
DEN210027
The Cooral System
October 14, 2022
K180375
The IQoolTM Warm System
May 18, 2018
K162523
The IQool System
May 3, 2017