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FDA 510(k)

智慧頸部刺激器

K 號:K200558 · 2021-10-04

決定日期2021-10-04
產品代碼NUH
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

Smart Neck Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Guandong Skg Intelligent Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-10-04 under 510(k) number K200558. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Smart Neck Stimulator?

Smart Neck Stimulator is a medical device that received FDA 510(k) clearance on 2021-10-04. The listed applicant is Guandong Skg Intelligent Technology Co., Ltd.. The 510(k) number is K200558.

When did Smart Neck Stimulator receive FDA 510(k) clearance?

Smart Neck Stimulator received FDA 510(k) clearance on 2021-10-04, under 510(k) number K200558.

Who is the listed applicant for Smart Neck Stimulator?

The FDA 510(k) record lists Guandong Skg Intelligent Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Smart Neck Stimulator?

The FDA product code for Smart Neck Stimulator is NUH.

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相關器械(代碼:NUH)

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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