K232844
- 510(k) number
- K232844
- Device name
- The IQoolTM System
- Applicant
- Braincool AB SE
- Product code
- DWJ — System, Thermal Regulating
- Decision date
- 2023-10-04
- Date received
- 2023-09-14
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K232844.pdf
Official FDA record: K232844
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.