K234029
- 510(k) number
- K234029
- Device name
- CEFALY Connected - OTC, CEFALY Connected - Rx
- Applicant
- Cefaly Technology BE
- Product code
- PCC — Stimulator, Nerve, Electrical, Transcutaneous, For M
- Decision date
- 2024-07-18
- Date received
- 2023-12-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K234029.pdf
Official FDA record: K234029
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.