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FDA 510(k)

GEN_2及GEN_3機械輪椅

K 號:K170701 · 2017-03-24

決定日期2017-03-24
產品代碼IOR
諮詢委員會PM
決定相當於

器材摘要

GEN_2 and GEN_3 Mechanical Wheelchairs is the device name listed in this FDA 510(k) record. The listed applicant is Free Wheelchair Mission. It received FDA 510(k) clearance on 2017-03-24 under 510(k) number K170701. 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 GEN_2 and GEN_3 Mechanical Wheelchairs?

GEN_2 and GEN_3 Mechanical Wheelchairs is a medical device that received FDA 510(k) clearance on 2017-03-24. The listed applicant is Free Wheelchair Mission. The 510(k) number is K170701.

When did GEN_2 and GEN_3 Mechanical Wheelchairs receive FDA 510(k) clearance?

GEN_2 and GEN_3 Mechanical Wheelchairs received FDA 510(k) clearance on 2017-03-24, under 510(k) number K170701.

Who is the listed applicant for GEN_2 and GEN_3 Mechanical Wheelchairs?

FDA 510(k) 記錄將自由輪椅使命列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for GEN_2 and GEN_3 Mechanical Wheelchairs?

The FDA product code for GEN_2 and GEN_3 Mechanical Wheelchairs is IOR.

相關臨床試驗

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。

其他以 Free Wheelchair Mission 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。

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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