K250363
- 510(k) number
- K250363
- Device name
- Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); Dept
- Applicant
- Beijing Sinovation Medical Technology Co., Ltd. CN
- Product code
- GZL — Electrode, Depth
- Decision date
- 2025-11-05
- Date received
- 2025-02-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250363.pdf
Official FDA record: K250363
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.