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Electrode, Depth

FDA product code GZL · 57 cleared devices

Class 2 Neurology
Regulation
21 CFR 882.1330
Review panel
NE
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
1980-11-19 – 2026-04-17
GZL 2025-11-05

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.

K number K250363

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