FDA 510(k)

CAC（閥控）算法

K 號：K240369 · 2024-09-27

決定日期2024-09-27

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

CAC (gated) Algorithm is the device name listed in this FDA 510(k) record. The listed applicant is BunkerHill Health. It received FDA 510(k) clearance on 2024-09-27 under 510(k) number K240369. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CAC (gated) Algorithm?

CAC (gated) Algorithm is a medical device that received FDA 510(k) clearance on 2024-09-27. The listed applicant is BunkerHill Health. The 510(k) number is K240369.

When did CAC (gated) Algorithm receive FDA 510(k) clearance?

CAC (gated) Algorithm received FDA 510(k) clearance on 2024-09-27, under 510(k) number K240369.

Who is the listed applicant for CAC (gated) Algorithm?

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

What is the FDA product code for CAC (gated) Algorithm?

The FDA product code for CAC (gated) Algorithm is JAK.

其他以 BunkerHill Health 為申請人之記錄

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相關器械（代碼：JAK）

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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