K241395
- 510(k) number
- K241395
- Device name
- Active System; Avenue8
- Applicant
- Caerus Corporation MN · US
- Product code
- ILX — Diathermy, Shortwave, For Use Other Than Applying Th
- Decision date
- 2024-12-18
- Date received
- 2024-05-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K241395.pdf
Official FDA record: K241395
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.