K251974
- 510(k) number
- K251974
- Device name
- Arctic Sun Temperature Management System (Model 5000)
- Applicant
- Medivance, Inc. CO · US
- Product code
- DWJ — System, Thermal Regulating
- Decision date
- 2025-10-24
- Date received
- 2025-06-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K251974.pdf
Official FDA record: K251974
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.