FDA 510(k)

VitalStream ART Connect; VitalStream-Hemo

K 號：K251275 · 2025-09-26

決定日期2025-09-26

產品代碼DXG

諮詢委員會履歷

決定相當於

器材摘要

VitalStream ART Connect; VitalStream-Hemo is the device name listed in this FDA 510(k) record. The listed applicant is Caretaker Medical. It received FDA 510(k) clearance on 2025-09-26 under 510(k) number K251275. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VitalStream ART Connect; VitalStream-Hemo?

VitalStream ART Connect; VitalStream-Hemo is a medical device that received FDA 510(k) clearance on 2025-09-26. The listed applicant is Caretaker Medical. The 510(k) number is K251275.

When did VitalStream ART Connect; VitalStream-Hemo receive FDA 510(k) clearance?

VitalStream ART Connect; VitalStream-Hemo received FDA 510(k) clearance on 2025-09-26, under 510(k) number K251275.

Who is the listed applicant for VitalStream ART Connect; VitalStream-Hemo?

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

What is the FDA product code for VitalStream ART Connect; VitalStream-Hemo?

The FDA product code for VitalStream ART Connect; VitalStream-Hemo is DXG.

其他以 Caretaker Medical 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。

K211588照護者平台，生命流平台，CT5

相關器械（代碼：DXG）

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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