FDA 510(k)

接收器套件、試驗套件、備用導線套件、无菌修復套件、可穿戴天線組裝套件及充電器套件

K 號：K170141 · 2017-05-02

決定日期2017-05-02

產品代碼GZB

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, Wearable Antenna Assembly Kit and Charger 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 2017-05-02 under 510(k) number K170141. The device is classified under product code GZB. 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, Wearable Antenna Assembly Kit and Charger Kit?

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit is a medical device that received FDA 510(k) clearance on 2017-05-02. The listed applicant is Stimwave Technologies Incorporated. The 510(k) number is K170141.

When did Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit receive FDA 510(k) clearance?

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit received FDA 510(k) clearance on 2017-05-02, under 510(k) number K170141.

Who is the listed applicant for Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger 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 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit?

The FDA product code for Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit is GZB.

其他以 Stimwave Technologies Incorporated 為申請人之記錄

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相關器械（代碼：GZB）

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。

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官方來源

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