MRopen EVO
K 號：K193116 · 2019-12-20
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器材摘要
MRopen EVO is the device name listed in this FDA 510(k) record. The listed applicant is Asg Superconductors S.P.A.. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K193116. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the MRopen EVO?
MRopen EVO is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Asg Superconductors S.P.A.. The 510(k) number is K193116.
When did MRopen EVO receive FDA 510(k) clearance?
MRopen EVO received FDA 510(k) clearance on 2019-12-20, under 510(k) number K193116.
Who is the listed applicant for MRopen EVO?
The FDA 510(k) record lists Asg Superconductors S.P.A. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MRopen EVO?
The FDA product code for MRopen EVO is LNH.
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其他以 Asg Superconductors S.P.A. 為申請人之記錄
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相關器械（代碼：LNH）
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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