FDA 510(k)

Vasoview Hemopro 3 電源供應器

K 號：K243918 · 2025-02-26

決定日期2025-02-26

產品代碼GEI

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Vasoview Hemopro 3 Power Supply is the device name listed in this FDA 510(k) record. The listed applicant is Maquet Cardiovascular, LLC. It received FDA 510(k) clearance on 2025-02-26 under 510(k) number K243918. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Vasoview Hemopro 3 Power Supply?

Vasoview Hemopro 3 Power Supply is a medical device that received FDA 510(k) clearance on 2025-02-26. The listed applicant is Maquet Cardiovascular, LLC. The 510(k) number is K243918.

When did Vasoview Hemopro 3 Power Supply receive FDA 510(k) clearance?

Vasoview Hemopro 3 Power Supply received FDA 510(k) clearance on 2025-02-26, under 510(k) number K243918.

Who is the listed applicant for Vasoview Hemopro 3 Power Supply?

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

What is the FDA product code for Vasoview Hemopro 3 Power Supply?

The FDA product code for Vasoview Hemopro 3 Power Supply is GEI.

其他以 Maquet Cardiovascular, LLC 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。

K252445Fusion Bioline 血管移植物 K251238Vasoview Hemopro 3內視鏡血管採集系統（VH-6000）；Vasoview Hemopro 3內視鏡血管採集系統搭配Vasoshield（VH-6001）；Vasoview Hemopro 3電源供應器（VH-6010）K233879Vasoview Hemopro 3內視鏡血管採集系統（VH-6000），Vasoview Hemopro 3內視鏡血管採集系統搭配Vasoshield（VH-6001），Vasoview Hemopro 3電源轉接器（VH-6020）K1919307 mm 延長長度內視鏡 K191947VASOVIEW HEMOPRO 延長線，VASOVIEW HEMOPRO 2 延長線，雙極延長線，固定距離，活動回電線 K153194VASOVIEW HemoPro內視鏡血管採集系統

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相關器械（代碼：GEI）

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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