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FDA 510(k)

接收組、試驗組、備用導線組、無菌修復組、SWAG組、SWAG配件組、充電組

K 號：K171366 · 2017-08-04

申請人Stimwave Technologies Inc., Dba Stimq, LLC
決定日期2017-08-04
產品代碼GZF
諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)
決定相當於

器材摘要

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit is the device name listed in this FDA 510(k) record. The listed applicant is Stimwave Technologies Inc., Dba Stimq, LLC. It received FDA 510(k) clearance on 2017-08-04 under 510(k) number K171366. The device is classified under product code GZF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit?

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit is a medical device that received FDA 510(k) clearance on 2017-08-04. The listed applicant is Stimwave Technologies Inc., Dba Stimq, LLC. The 510(k) number is K171366.

When did Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit receive FDA 510(k) clearance?

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit received FDA 510(k) clearance on 2017-08-04, under 510(k) number K171366.

Who is the listed applicant for Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit?

The FDA 510(k) record lists Stimwave Technologies Inc., Dba Stimq, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit?

The FDA product code for Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit is GZF.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：GZF）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253877刺激試驗神經調節系統Bioventus, LLCK243782刺激試驗神經調節系統Bioventus, LLCK243678塔利斯曼神經調節系統Bioventus, LLCK232415Nalu神經刺激系統用於週邊神經刺激Boston Scientific NeuromodulationK233162自由周邊神經刺激器（PNS）系統CuronixK221303Neuspera Nuity 系統Neuspera Medical, Inc.

官方來源

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