K243698

Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT

510(k) 号: K243698
器械名称: Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT
申请人: Brainlab AG DE
产品代码: HAW — Neurological Stereotaxic Instrument
批准日期: 2025-01-28
受理日期: 2024-11-29
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Neurology

PDF下载 510(k) Summary本站存档 · 2.6 MB · FDA 公有领域文件

也可从 FDA 官方下载： K243698.pdf

FDA 官方记录： K243698

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。