K231211
- 510(k) number
- K231211
- Device name
- Medline ComfortTemp Patient Warming System
- Applicant
- Medline Industries, LP IL · US
- Product code
- DWJ — System, Thermal Regulating
- Decision date
- 2023-12-01
- Date received
- 2023-04-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K231211.pdf
Official FDA record: K231211
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.