K232508
- 510(k) number
- K232508
- Device name
- Barrier EasyWarm Active Self-Warming Blanket
- Applicant
- Molnlycke Health Care Us, LLC GA · US
- Product code
- DWJ — System, Thermal Regulating
- Decision date
- 2023-09-15
- Date received
- 2023-08-18
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K232508.pdf
Official FDA record: K232508
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.