SUNCO機械輪椅，型號SKW-9003
K 號：K153328 · 2016-07-20
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器材摘要
SUNCO Mechanical Wheelchair, model SKW-9003 is the device name listed in this FDA 510(k) record. The listed applicant is Danyang Sunco Machinery Co., Ltd.. It received FDA 510(k) clearance on 2016-07-20 under 510(k) number K153328. 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 SUNCO Mechanical Wheelchair, model SKW-9003?
SUNCO Mechanical Wheelchair, model SKW-9003 is a medical device that received FDA 510(k) clearance on 2016-07-20. The listed applicant is Danyang Sunco Machinery Co., Ltd.. The 510(k) number is K153328.
When did SUNCO Mechanical Wheelchair, model SKW-9003 receive FDA 510(k) clearance?
SUNCO Mechanical Wheelchair, model SKW-9003 received FDA 510(k) clearance on 2016-07-20, under 510(k) number K153328.
Who is the listed applicant for SUNCO Mechanical Wheelchair, model SKW-9003?
The FDA 510(k) record lists Danyang Sunco Machinery Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SUNCO Mechanical Wheelchair, model SKW-9003?
The FDA product code for SUNCO Mechanical Wheelchair, model SKW-9003 is IOR.
相關臨床試驗
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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。
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官方來源
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