FDA 510(k)

STAR 阿波羅™ 地圖系統

K 號：K240509 · 2024-07-26

決定日期2024-07-26

產品代碼DQK

諮詢委員會履歷

決定相當於

器材摘要

STAR Apollo™ Mapping System is the device name listed in this FDA 510(k) record. The listed applicant is Rhythm AI, Ltd.. It received FDA 510(k) clearance on 2024-07-26 under 510(k) number K240509. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the STAR Apollo™ Mapping System?

STAR Apollo™ Mapping System is a medical device that received FDA 510(k) clearance on 2024-07-26. The listed applicant is Rhythm AI, Ltd.. The 510(k) number is K240509.

When did STAR Apollo™ Mapping System receive FDA 510(k) clearance?

STAR Apollo™ Mapping System received FDA 510(k) clearance on 2024-07-26, under 510(k) number K240509.

Who is the listed applicant for STAR Apollo™ Mapping System?

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

What is the FDA product code for STAR Apollo™ Mapping System?

The FDA product code for STAR Apollo™ Mapping System is DQK.

其他以 Rhythm AI, Ltd. 為申請人之記錄

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K253733STAR 阿波羅™ 地圖系統

相關器械（代碼：DQK）

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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