K243942
- 510(k) number
- K243942
- Device name
- Arctic Sun Stat Temperature Management System
- Applicant
- Medivance, Inc. CO · US
- Product code
- DWJ — System, Thermal Regulating
- Decision date
- 2025-04-30
- Date received
- 2024-12-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K243942.pdf
Official FDA record: K243942
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.