FDA 510(k)

電動滑板車（型號：M2020）

K 號：K230001 · 2023-07-05

申請人Guangdong Prestige Technology Co., Ltd.

決定日期2023-07-05

產品代碼INI

諮詢委員會PM

決定相當於

器材摘要

Electric Scooter (Model: M2020) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Prestige Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-07-05 under 510(k) number K230001. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Electric Scooter (Model: M2020)?

Electric Scooter (Model: M2020) is a medical device that received FDA 510(k) clearance on 2023-07-05. The listed applicant is Guangdong Prestige Technology Co., Ltd.. The 510(k) number is K230001.

When did Electric Scooter (Model: M2020) receive FDA 510(k) clearance?

Electric Scooter (Model: M2020) received FDA 510(k) clearance on 2023-07-05, under 510(k) number K230001.

Who is the listed applicant for Electric Scooter (Model: M2020)?

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

What is the FDA product code for Electric Scooter (Model: M2020)?

The FDA product code for Electric Scooter (Model: M2020) is INI.

其他以 Guangdong Prestige Technology Co., 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。

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相關器械（代碼：INI）

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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