MRIaudio PREM 系統搭配 MRIview
K 號：K193102 · 2020-01-06
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器材摘要
MRIaudio PREM System with MRIview is the device name listed in this FDA 510(k) record. The listed applicant is Mriaudio, Inc.. It received FDA 510(k) clearance on 2020-01-06 under 510(k) number K193102. 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 MRIaudio PREM System with MRIview?
MRIaudio PREM System with MRIview is a medical device that received FDA 510(k) clearance on 2020-01-06. The listed applicant is Mriaudio, Inc.. The 510(k) number is K193102.
When did MRIaudio PREM System with MRIview receive FDA 510(k) clearance?
MRIaudio PREM System with MRIview received FDA 510(k) clearance on 2020-01-06, under 510(k) number K193102.
Who is the listed applicant for MRIaudio PREM System with MRIview?
The FDA 510(k) record lists Mriaudio, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MRIaudio PREM System with MRIview?
The FDA product code for MRIaudio PREM System with MRIview is LNH.
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。
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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