FDA 510(k)

STIMPOD NMS460 神經刺激器

K 號：K161091 · 2017-01-18

決定日期2017-01-18

產品代碼GZJ

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

STIMPOD NMS460 Nerve Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Xavant Technology (Pty), Ltd.. It received FDA 510(k) clearance on 2017-01-18 under 510(k) number K161091. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the STIMPOD NMS460 Nerve Stimulator?

STIMPOD NMS460 Nerve Stimulator is a medical device that received FDA 510(k) clearance on 2017-01-18. The listed applicant is Xavant Technology (Pty), Ltd.. The 510(k) number is K161091.

When did STIMPOD NMS460 Nerve Stimulator receive FDA 510(k) clearance?

STIMPOD NMS460 Nerve Stimulator received FDA 510(k) clearance on 2017-01-18, under 510(k) number K161091.

Who is the listed applicant for STIMPOD NMS460 Nerve Stimulator?

The FDA 510(k) record lists Xavant Technology (Pty), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STIMPOD NMS460 Nerve Stimulator?

The FDA product code for STIMPOD NMS460 Nerve Stimulator is GZJ.

其他以 Xavant Technology (Pty), Ltd. 為申請人之記錄

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。

K213049STIMPOD NMS450 神經刺激器

相關器械（代碼：GZJ）

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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