FDA 510(k)

霍羅斯移動式設備

K 號：K242552 · 2025-04-08

決定日期2025-04-08

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Horos Mobile 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 2025-04-08 under 510(k) number K242552. 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 Mobile?

Horos Mobile is a medical device that received FDA 510(k) clearance on 2025-04-08. The listed applicant is Icat Solutions, Ltd.. The 510(k) number is K242552.

When did Horos Mobile receive FDA 510(k) clearance?

Horos Mobile received FDA 510(k) clearance on 2025-04-08, under 510(k) number K242552.

Who is the listed applicant for Horos Mobile?

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 Mobile?

The FDA product code for Horos Mobile is LLZ.

其他以 Icat Solutions, Ltd. 為申請人之記錄

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K232589Horos MD™

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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