快速中風
K 號：K163281 · 2017-01-26
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器材摘要
FastStroke is the device name listed in this FDA 510(k) record. The listed applicant is Gef Medical Systems Scs. It received FDA 510(k) clearance on 2017-01-26 under 510(k) number K163281. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the FastStroke?
FastStroke is a medical device that received FDA 510(k) clearance on 2017-01-26. The listed applicant is Gef Medical Systems Scs. The 510(k) number is K163281.
When did FastStroke receive FDA 510(k) clearance?
FastStroke received FDA 510(k) clearance on 2017-01-26, under 510(k) number K163281.
Who is the listed applicant for FastStroke?
The FDA 510(k) record lists Gef Medical Systems Scs as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FastStroke?
The FDA product code for FastStroke is JAK.
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相關器械（代碼：JAK）
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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