K232627
- 510(k) number
- K232627
- Device name
- HotDog Warming Mattress + Return Electrode
- Applicant
- Augustine Temperature Management, LLC MN · US
- Product code
- DWJ — System, Thermal Regulating
- Decision date
- 2024-04-18
- Date received
- 2023-08-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K232627.pdf
Official FDA record: K232627
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.