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FDA 510(k)

神經42 MRI系統

K 號:K232644 · 2024-02-08

申請人Neuro42, Inc.
決定日期2024-02-08
產品代碼LNH
諮詢委員會RA
決定相當於

器材摘要

neuro42 MRI System is the device name listed in this FDA 510(k) record. The listed applicant is Neuro42, Inc.. It received FDA 510(k) clearance on 2024-02-08 under 510(k) number K232644. 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 neuro42 MRI System?

neuro42 MRI System is a medical device that received FDA 510(k) clearance on 2024-02-08. The listed applicant is Neuro42, Inc.. The 510(k) number is K232644.

When did neuro42 MRI System receive FDA 510(k) clearance?

neuro42 MRI System received FDA 510(k) clearance on 2024-02-08, under 510(k) number K232644.

Who is the listed applicant for neuro42 MRI System?

The FDA 510(k) record lists Neuro42, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for neuro42 MRI System?

The FDA product code for neuro42 MRI System is LNH.

相關臨床試驗

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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。

官方來源

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