| Device Classification Name |
Electrode, Depth
|
|---|
| 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. |
| Rm. 218, 2nd Floor, Bldg. 1, # 1, Hangfeng Rd. |
| Fengtai District |
|
Beijing,
CN
100070
|
|
| Applicant Contact |
Lina Wang |
| Correspondent |
| Beijing Sinovation Medical Technology Co., Ltd. |
| Rm. 218, 2nd Floor, Bldg. 1, # 1, Hangfeng Rd. |
| Fengtai District |
|
Beijing,
CN
100070
|
|
| Correspondent Contact |
Lina Wang |
| Regulation Number | 882.1330 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 02/10/2025 |
|---|
| Decision Date | 11/05/2025 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Neurology
|
|---|
| 510k Review Panel |
Neurology
|
|---|
| Summary |
Summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|
|
|
