FDA.report

510(k) K232844

Device
The IQoolTM System
Applicant
Braincool AB
510(k) number
K232844
Product code
DWJ
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-04
Date received
2023-09-14
Regulation
870.5900
Classification name
System, Thermal Regulating
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Martin Waleij
Address
Medicon Village Scheelevagen 2 Lund SE 223 81 223 81

FDA Registration Numbers

Source Documents

510(k) summary PDF

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