FDA 510(k)

SupaChair 電動輪椅：COMBI 18、COMBI 18SP、COMBI 20、COMBI 20SP

K 號：K173313 · 2018-02-13

決定日期2018-02-13

產品代碼ITI

諮詢委員會PM

決定相當於

器材摘要

SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP 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 2018-02-13 under 510(k) number K173313. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP?

SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP is a medical device that received FDA 510(k) clearance on 2018-02-13. The listed applicant is Eurogreen International, Inc.. The 510(k) number is K173313.

When did SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP receive FDA 510(k) clearance?

SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP received FDA 510(k) clearance on 2018-02-13, under 510(k) number K173313.

Who is the listed applicant for SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP?

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 SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP?

The FDA product code for SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP is ITI.

其他以 Eurogreen International, Inc. 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。

K182631SupaScoota 電動車輛 - 斯巴達（相撲）/ 斯巴達 SP（相撲 SP）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。

相關器械（代碼：ITI）

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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