K252861
- 510(k) number
- K252861
- Device name
- Warming System
- Applicant
- Hangzhou Tappa Medical Technology Co., Ltd. CN
- Product code
- DWJ — System, Thermal Regulating
- Decision date
- 2026-04-07
- Date received
- 2025-09-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252861.pdf
Official FDA record: K252861
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.