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FDA 510(k)

Horos MD™

K 號:K232589 · 2024-01-03

決定日期2024-01-03
產品代碼LLZ
諮詢委員會RA
決定相當於

器材摘要

Horos MD™ is the device name listed in this FDA 510(k) record. The listed applicant is Icat Solutions, Ltd.. It received FDA 510(k) clearance on 2024-01-03 under 510(k) number K232589. 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 Horos MD™?

Horos MD™ is a medical device that received FDA 510(k) clearance on 2024-01-03. The listed applicant is Icat Solutions, Ltd.. The 510(k) number is K232589.

When did Horos MD™ receive FDA 510(k) clearance?

Horos MD™ received FDA 510(k) clearance on 2024-01-03, under 510(k) number K232589.

Who is the listed applicant for Horos MD™?

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

What is the FDA product code for Horos MD™?

The FDA product code for Horos MD™ is LLZ.

相關臨床試驗

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其他以 Icat Solutions, Ltd. 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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