FDA 510(k)

STIMPOD NMS450 神經刺激器

K 號：K213049 · 2022-10-16

決定日期2022-10-16

產品代碼BXN

諮詢委員會AN

決定相當於

器材摘要

STIMPOD NMS450 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 2022-10-16 under 510(k) number K213049. The device is classified under product code BXN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the STIMPOD NMS450 Nerve Stimulator?

STIMPOD NMS450 Nerve Stimulator is a medical device that received FDA 510(k) clearance on 2022-10-16. The listed applicant is Xavant Technology (Pty), Ltd.. The 510(k) number is K213049.

When did STIMPOD NMS450 Nerve Stimulator receive FDA 510(k) clearance?

STIMPOD NMS450 Nerve Stimulator received FDA 510(k) clearance on 2022-10-16, under 510(k) number K213049.

Who is the listed applicant for STIMPOD NMS450 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 NMS450 Nerve Stimulator?

The FDA product code for STIMPOD NMS450 Nerve Stimulator is BXN.

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

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K161091STIMPOD NMS460 神經刺激器

相關器械（代碼：BXN）

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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