K260278
- 510(k) number
- K260278
- Device name
- ThermAffyx(TM) Patient Safety System
- Applicant
- Stihler Electronic GmbH DE
- Product code
- DWJ — System, Thermal Regulating
- Decision date
- 2026-07-08
- Date received
- 2026-01-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K260278.pdf
Official FDA record: K260278
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.