FDA 510(k)

MRCP+ v1.0

K 號：K183133 · 2019-01-09

決定日期2019-01-09

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

MRCP+ v1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Perspectum Diagnostics, Ltd.. It received FDA 510(k) clearance on 2019-01-09 under 510(k) number K183133. 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+ v1.0?

MRCP+ v1.0 is a medical device that received FDA 510(k) clearance on 2019-01-09. The listed applicant is Perspectum Diagnostics, Ltd.. The 510(k) number is K183133.

When did MRCP+ v1.0 receive FDA 510(k) clearance?

MRCP+ v1.0 received FDA 510(k) clearance on 2019-01-09, under 510(k) number K183133.

Who is the listed applicant for MRCP+ v1.0?

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

What is the FDA product code for MRCP+ v1.0?

The FDA product code for MRCP+ v1.0 is LLZ.

其他以 Perspectum Diagnostics, Ltd. 為申請人之記錄

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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。

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