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FDA 510(k)

神經與肌肉刺激器

K 號:K193276 · 2020-09-23

決定日期2020-09-23
產品代碼GZI
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

Nerve and Muscle Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Xft Medical Limited. It received FDA 510(k) clearance on 2020-09-23 under 510(k) number K193276. The device is classified under product code GZI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Nerve and Muscle Stimulator?

Nerve and Muscle Stimulator is a medical device that received FDA 510(k) clearance on 2020-09-23. The listed applicant is Shenzhen Xft Medical Limited. The 510(k) number is K193276.

When did Nerve and Muscle Stimulator receive FDA 510(k) clearance?

Nerve and Muscle Stimulator received FDA 510(k) clearance on 2020-09-23, under 510(k) number K193276.

Who is the listed applicant for Nerve and Muscle Stimulator?

The FDA 510(k) record lists Shenzhen Xft Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nerve and Muscle Stimulator?

The FDA product code for Nerve and Muscle Stimulator is GZI.

相關臨床試驗

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其他以 Shenzhen Xft Medical Limited 為申請人之記錄

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相關器械(代碼:GZI)

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。

官方來源

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