CereFlow™ V1.2
K 號：K211059 · 2023-03-31
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器材摘要
CereFlow™ V1.2 is the device name listed in this FDA 510(k) record. The listed applicant is Translational Mri, LLC. It received FDA 510(k) clearance on 2023-03-31 under 510(k) number K211059. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the CereFlow™ V1.2?
CereFlow™ V1.2 is a medical device that received FDA 510(k) clearance on 2023-03-31. The listed applicant is Translational Mri, LLC. The 510(k) number is K211059.
When did CereFlow™ V1.2 receive FDA 510(k) clearance?
CereFlow™ V1.2 received FDA 510(k) clearance on 2023-03-31, under 510(k) number K211059.
Who is the listed applicant for CereFlow™ V1.2?
The FDA 510(k) record lists Translational Mri, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CereFlow™ V1.2?
The FDA product code for CereFlow™ V1.2 is LLZ.
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相關器械（代碼：LLZ）
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。
官方來源
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