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FDA 510(k)

MRCP+版本2(MRCP+ v2)

K 號:K233930 · 2024-03-13

申請人Perspectum
決定日期2024-03-13
產品代碼LLZ
諮詢委員會RA
決定相當於

器材摘要

MRCP+ version 2 (MRCP+ v2) is the device name listed in this FDA 510(k) record. The listed applicant is Perspectum. It received FDA 510(k) clearance on 2024-03-13 under 510(k) number K233930. 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 MRCP+ version 2 (MRCP+ v2)?

MRCP+ version 2 (MRCP+ v2) is a medical device that received FDA 510(k) clearance on 2024-03-13. The listed applicant is Perspectum. The 510(k) number is K233930.

When did MRCP+ version 2 (MRCP+ v2) receive FDA 510(k) clearance?

MRCP+ version 2 (MRCP+ v2) received FDA 510(k) clearance on 2024-03-13, under 510(k) number K233930.

Who is the listed applicant for MRCP+ version 2 (MRCP+ v2)?

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

What is the FDA product code for MRCP+ version 2 (MRCP+ v2)?

The FDA product code for MRCP+ version 2 (MRCP+ v2) is LLZ.

相關臨床試驗

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其他以 Perspectum 為申請人之記錄

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: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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