FDA 510(k)

心焦點 (V.1.1.1)

K 號：K242807 · 2025-04-04

申請人Deski

決定日期2025-04-04

產品代碼QJU

諮詢委員會RA

決定相當於

器材摘要

HeartFocus (V.1.1.1) is the device name listed in this FDA 510(k) record. The listed applicant is Deski. It received FDA 510(k) clearance on 2025-04-04 under 510(k) number K242807. The device is classified under product code QJU. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HeartFocus (V.1.1.1)?

HeartFocus (V.1.1.1) is a medical device that received FDA 510(k) clearance on 2025-04-04. The listed applicant is Deski. The 510(k) number is K242807.

When did HeartFocus (V.1.1.1) receive FDA 510(k) clearance?

HeartFocus (V.1.1.1) received FDA 510(k) clearance on 2025-04-04, under 510(k) number K242807.

Who is the listed applicant for HeartFocus (V.1.1.1)?

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

What is the FDA product code for HeartFocus (V.1.1.1)?

The FDA product code for HeartFocus (V.1.1.1) is QJU.

其他以 Deski 為申請人之記錄

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K260780心焦點

相關器械（代碼：QJU）

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。

K260338ThinkSono 指導ThinkSono GmbH K260780心焦點Deski K251416超視導引Ultrasight , Ltd.K243065心臟導引設備Caption Health, Inc.K223347超視AI導引系統Ultrasight, Inc.K201992標題指引Caption Health

官方來源

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