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FDA 510(k)

鎮江保證機械輪椅,型號:K1

K 號:K231320 · 2023-06-05

決定日期2023-06-05
產品代碼IOR
諮詢委員會PM
決定相當於

器材摘要

Zhenjiang Assure Mechanical Wheelchair,model:K1 is the device name listed in this FDA 510(k) record. The listed applicant is Zhenjiang Assure Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2023-06-05 under 510(k) number K231320. 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 Zhenjiang Assure Mechanical Wheelchair,model:K1?

Zhenjiang Assure Mechanical Wheelchair,model:K1 is a medical device that received FDA 510(k) clearance on 2023-06-05. The listed applicant is Zhenjiang Assure Medical Equipment Co., Ltd.. The 510(k) number is K231320.

When did Zhenjiang Assure Mechanical Wheelchair,model:K1 receive FDA 510(k) clearance?

Zhenjiang Assure Mechanical Wheelchair,model:K1 received FDA 510(k) clearance on 2023-06-05, under 510(k) number K231320.

Who is the listed applicant for Zhenjiang Assure Mechanical Wheelchair,model:K1?

FDA 510(k) 記錄將鎮江保證醫療設備有限公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Zhenjiang Assure Mechanical Wheelchair,model:K1?

The FDA product code for Zhenjiang Assure Mechanical Wheelchair,model:K1 is IOR.

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其他以 Zhenjiang Assure Medical Equipment Co., Ltd. 為申請人之記錄

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相關器械(代碼:IOR)

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