FDA 510(k)

刺激器套件，试验套件，备用导线套件，可穿戴组件套件

K号: K180981 · 2018-09-19

决定日期2018-09-19

产品代码GZB

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决定实质等同

器械摘要

Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit is the device name listed in this FDA 510(k) record. The listed applicant is Stimwave Technologies Incorporated. It received FDA 510(k) clearance on 2018-09-19 under 510(k) number K180981. 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 Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit?

Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit is a medical device that received FDA 510(k) clearance on 2018-09-19. The listed applicant is Stimwave Technologies Incorporated. The 510(k) number is K180981.

When did Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit receive FDA 510(k) clearance?

Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit received FDA 510(k) clearance on 2018-09-19, under 510(k) number K180981.

Who is the listed applicant for Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit?

The FDA 510(k) record lists Stimwave Technologies Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit?

The FDA product code for Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit is GZB.

列明Stimwave Technologies Incorporated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。

K182720Freedom脊髓刺激器（SCS）系统 K172644Sandshark 注射锚套装，注射器手柄，带锚的加载杆，加载底座 K170141接收器套件，试验套件，备用导联套件，无菌修订套件，可穿戴天线组件套件和充电器套件 K162161接收器套件，试验套件，备用导联套件，无菌修订套件，可穿戴天线组件套件和充电器套件 K160600Freedom脊髓刺激器系统

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 Neuromodulation K221376Nalu 神经刺激系统Boston Scientific Neuromodulation K203547Nalu 神经刺激系统Boston Scientific Neuromodulation K202274Nalu 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 Neuromodulation K201618Nalu 神经刺激 SCS 系统Boston Scientific Neuromodulation K191466SandShark 注射锚 (SIA) 系统Stimwave Technologies, Inc.

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