Medical Device Manufacturer · SE , Medicon Village

Braincool AB - FDA 510(k) Cleared Devices

4 submissions · 3 cleared · Since 2017
4
Total
3
Cleared
1
Denied
FDA 510(k) Regulatory Record - Braincool AB Cardiovascular ✕
3 devices
1-3 of 3
Cleared Oct 04, 2023
The IQoolTM System
K232844 · DWJ
Cardiovascular · 20d
Cleared May 18, 2018
The IQoolTM Warm System
K180375 · DWJ
Cardiovascular · 95d
Cleared May 03, 2017
The IQool System
K162523 · NZE
Cardiovascular · 236d
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All4 Cardiovascular 3 Dental 1