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FDA 510(k)

手動輪椅 W54

K 號:K180309 · 2019-05-03

決定日期2019-05-03
產品代碼IOR
諮詢委員會PM
決定相當於

器材摘要

Manual Wheelchair W54 is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Jumao Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2019-05-03 under 510(k) number K180309. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Manual Wheelchair W54?

Manual Wheelchair W54 is a medical device that received FDA 510(k) clearance on 2019-05-03. The listed applicant is Jiangsu Jumao Medical Equipment Co., Ltd.. The 510(k) number is K180309.

When did Manual Wheelchair W54 receive FDA 510(k) clearance?

Manual Wheelchair W54 received FDA 510(k) clearance on 2019-05-03, under 510(k) number K180309.

Who is the listed applicant for Manual Wheelchair W54?

The FDA 510(k) record lists Jiangsu Jumao Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Manual Wheelchair W54?

The FDA product code for Manual Wheelchair W54 is IOR.

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相關器械(代碼:IOR)

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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