MRIaudio PREM 系統
K 號：K180100 · 2018-06-14
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器材摘要
MRIaudio PREM System is the device name listed in this FDA 510(k) record. The listed applicant is Mriaudio. It received FDA 510(k) clearance on 2018-06-14 under 510(k) number K180100. 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?
MRIaudio PREM System is a medical device that received FDA 510(k) clearance on 2018-06-14. The listed applicant is Mriaudio. The 510(k) number is K180100.
When did MRIaudio PREM System receive FDA 510(k) clearance?
MRIaudio PREM System received FDA 510(k) clearance on 2018-06-14, under 510(k) number K180100.
Who is the listed applicant for MRIaudio PREM System?
The FDA 510(k) record lists Mriaudio as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MRIaudio PREM System?
The FDA product code for MRIaudio PREM System is LNH.
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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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