FDA 510(k)

合併Hemo，型號RCSV2

K 號：K233326 · 2024-06-21

決定日期2024-06-21

產品代碼DQK

諮詢委員會履歷

決定相當於

器材摘要

Merge Hemo, Model RCSV2 is the device name listed in this FDA 510(k) record. The listed applicant is Merge Healthcare Incorporated. It received FDA 510(k) clearance on 2024-06-21 under 510(k) number K233326. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Merge Hemo, Model RCSV2?

Merge Hemo, Model RCSV2 is a medical device that received FDA 510(k) clearance on 2024-06-21. The listed applicant is Merge Healthcare Incorporated. The 510(k) number is K233326.

When did Merge Hemo, Model RCSV2 receive FDA 510(k) clearance?

Merge Hemo, Model RCSV2 received FDA 510(k) clearance on 2024-06-21, under 510(k) number K233326.

Who is the listed applicant for Merge Hemo, Model RCSV2?

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

What is the FDA product code for Merge Hemo, Model RCSV2?

The FDA product code for Merge Hemo, Model RCSV2 is DQK.

其他以 Merge Healthcare Incorporated 為申請人之記錄

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相關器械（代碼：DQK）

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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