K240668
- 510(k) number
- K240668
- Device name
- Amydi-med Disposable Non-invasive EEG electrodes
- Applicant
- Shenzhen Amydi-Med Electrics Tech Co., Ltd. CN
- Product code
- GXY — Electrode, Cutaneous
- Decision date
- 2024-03-19
- Date received
- 2024-03-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K240668.pdf
Official FDA record: K240668
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.