Nalu 神经刺激 SCS 系统
K号: K201618 · 2020-07-15
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决定日期2020-07-15
产品代码GZB
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
Nalu Neurostimulation SCS system is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Neuromodulation. It received FDA 510(k) clearance on 2020-07-15 under 510(k) number K201618. The device is classified under product code GZB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Nalu Neurostimulation SCS system?
Nalu Neurostimulation SCS system is a medical device that received FDA 510(k) clearance on 2020-07-15. The listed applicant is Boston Scientific Neuromodulation. The 510(k) number is K201618.
When did Nalu Neurostimulation SCS system receive FDA 510(k) clearance?
Nalu Neurostimulation SCS system received FDA 510(k) clearance on 2020-07-15, under 510(k) number K201618.
Who is the listed applicant for Nalu Neurostimulation SCS system?
The FDA 510(k) record lists Boston Scientific Neuromodulation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Nalu Neurostimulation SCS system?
The FDA product code for Nalu Neurostimulation SCS system is GZB.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
列明Boston Scientific Neuromodulation为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：GZB）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K233801Nalu神经刺激系统用于脊髓刺激；Nalu神经刺激系统用于周围神经刺激Boston Scientific NeuromodulationK221376Nalu 神经刺激系统Boston Scientific NeuromodulationK203547Nalu 神经刺激系统Boston Scientific NeuromodulationK202274Nalu 神经刺激套件（lnte:gmted 40 em：单8/双8），Nalu 神经刺激套件（端口，2 em：单8/双8），40 cm/ 60 cm/ 60 em 试验/延长线套件，患者套件和备用套件Boston Scientific NeuromodulationK191466SandShark 注射锚 (SIA) 系统Stimwave Technologies, Inc.K190960Nalu 领导空白 (50cm)Boston Scientific Neuromodulation
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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