FDA 510(k)

SupaScoota 電動車輛 - 斯巴達（相撲）/ 斯巴達 SP（相撲 SP）

K 號：K182631 · 2019-09-19

決定日期2019-09-19

產品代碼INI

諮詢委員會PM

決定相當於

器材摘要

SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP) is the device name listed in this FDA 510(k) record. The listed applicant is Eurogreen International, Inc.. It received FDA 510(k) clearance on 2019-09-19 under 510(k) number K182631. 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 SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)?

SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP) is a medical device that received FDA 510(k) clearance on 2019-09-19. The listed applicant is Eurogreen International, Inc.. The 510(k) number is K182631.

When did SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP) receive FDA 510(k) clearance?

SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP) received FDA 510(k) clearance on 2019-09-19, under 510(k) number K182631.

Who is the listed applicant for SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)?

The FDA 510(k) record lists Eurogreen International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)?

The FDA product code for SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP) is INI.

其他以 Eurogreen International, Inc. 為申請人之記錄

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K173315SupaChair 電動輪椅注意事項：此翻譯僅根據「medical-regulatory-v1」政策進行，並保留公司/產品名稱、FDA、510(k)、PMA、NCT、PMID、識別碼和網址。K173313SupaChair 電動輪椅：COMBI 18、COMBI 18SP、COMBI 20、COMBI 20SP

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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