FDA 510(k)

1CMR Pro

K 號：K242062 · 2024-11-15

決定日期2024-11-15

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

1CMR Pro is the device name listed in this FDA 510(k) record. The listed applicant is Mycardium AI Limited. It received FDA 510(k) clearance on 2024-11-15 under 510(k) number K242062. 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 1CMR Pro?

1CMR Pro is a medical device that received FDA 510(k) clearance on 2024-11-15. The listed applicant is Mycardium AI Limited. The 510(k) number is K242062.

When did 1CMR Pro receive FDA 510(k) clearance?

1CMR Pro received FDA 510(k) clearance on 2024-11-15, under 510(k) number K242062.

Who is the listed applicant for 1CMR Pro?

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

What is the FDA product code for 1CMR Pro?

The FDA product code for 1CMR Pro is LLZ.

其他以 Mycardium AI Limited 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。

K250670EchoConfidence (美國)

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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官方來源

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