FDA 510(k)

知情生命核心應用程式（IVC App）（v2.0.0.2.0.0）

K 號：K250078 · 2025-05-30

決定日期2025-05-30

產品代碼QME

諮詢委員會履歷

決定相當於

器材摘要

Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) is the device name listed in this FDA 510(k) record. The listed applicant is Mindset Medical, Inc.. It received FDA 510(k) clearance on 2025-05-30 under 510(k) number K250078. The device is classified under product code QME. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)?

Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) is a medical device that received FDA 510(k) clearance on 2025-05-30. The listed applicant is Mindset Medical, Inc.. The 510(k) number is K250078.

When did Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) receive FDA 510(k) clearance?

Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) received FDA 510(k) clearance on 2025-05-30, under 510(k) number K250078.

Who is the listed applicant for Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)?

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

What is the FDA product code for Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)?

The FDA product code for Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) is QME.

其他以 Mindset Medical, Inc. 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。

K241633知情生命核心應用程式（IVC App）

相關器械（代碼：QME）

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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