FDA 510(k)

AST Model MA012 和 MS019 康復輪椅

K 號：K181795 · 2018-09-25

申請人Sichuan Ast Medical Equipment Co., Ltd.

決定日期2018-09-25

產品代碼IOR

諮詢委員會PM

決定相當於

器材摘要

AST Model MA012 and MS019 Rehab Wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Sichuan Ast Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2018-09-25 under 510(k) number K181795. 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 AST Model MA012 and MS019 Rehab Wheelchair?

AST Model MA012 and MS019 Rehab Wheelchair is a medical device that received FDA 510(k) clearance on 2018-09-25. The listed applicant is Sichuan Ast Medical Equipment Co., Ltd.. The 510(k) number is K181795.

When did AST Model MA012 and MS019 Rehab Wheelchair receive FDA 510(k) clearance?

AST Model MA012 and MS019 Rehab Wheelchair received FDA 510(k) clearance on 2018-09-25, under 510(k) number K181795.

Who is the listed applicant for AST Model MA012 and MS019 Rehab Wheelchair?

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

What is the FDA product code for AST Model MA012 and MS019 Rehab Wheelchair?

The FDA product code for AST Model MA012 and MS019 Rehab Wheelchair is IOR.

其他以 Sichuan Ast Medical Equipment Co., Ltd. 為申請人之記錄

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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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