K240125
- 510(k) number
- K240125
- Device name
- Therm-X (Home); Therm-X (AT)
- Applicant
- Zenith Technical Innovations IL · US
- Product code
- JOW — Sleeve, Limb, Compressible
- Decision date
- 2024-06-21
- Date received
- 2024-01-16
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K240125.pdf
Official FDA record: K240125
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.