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FDA 510(k)

Quingo 飛行移動輪椅

K 號:K171256 · 2017-06-08

決定日期2017-06-08
產品代碼INI
諮詢委員會PM
決定相當於

器材摘要

Quingo Flyte Mobility Scooter is the device name listed in this FDA 510(k) record. The listed applicant is Agile Distributors, LLC. It received FDA 510(k) clearance on 2017-06-08 under 510(k) number K171256. 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 Quingo Flyte Mobility Scooter?

Quingo Flyte Mobility Scooter is a medical device that received FDA 510(k) clearance on 2017-06-08. The listed applicant is Agile Distributors, LLC. The 510(k) number is K171256.

When did Quingo Flyte Mobility Scooter receive FDA 510(k) clearance?

Quingo Flyte Mobility Scooter received FDA 510(k) clearance on 2017-06-08, under 510(k) number K171256.

Who is the listed applicant for Quingo Flyte Mobility Scooter?

The FDA 510(k) record lists Agile Distributors, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quingo Flyte Mobility Scooter?

The FDA product code for Quingo Flyte Mobility Scooter is INI.

相關臨床試驗

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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。

官方來源

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