K241883
- 510(k) 号
- K241883
- 器械名称
- DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)
- 申请人
- Pro Med Instruments GmbH DE
- 产品代码
- HBL — Holder, Head, Neurosurgical (Skull Clamp)
- 批准日期
- 2024-07-26
- 受理日期
- 2024-06-28
- 决定
- Substantially Equivalent
- 审查途径
- Special
- 咨询委员会
- Neurology
510(k) Summary(FDA 官方 PDF): K241883.pdf
FDA 官方记录: K241883
数据来自 openFDA 510(k) 数据集(CC0 公有领域),以 FDA 现行记录为准。510(k) 许可不等于 FDA 认证或批准。