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FDA 510(k)

HemoSphere先進監控器，遠控取景器，HemoSphere先進監控平台

K 號：K211465 · 2021-07-08

申請人Edwards Lfesciences
決定日期2021-07-08
產品代碼DQK
諮詢委員會履歷
決定相當於

器材摘要

HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lfesciences. It received FDA 510(k) clearance on 2021-07-08 under 510(k) number K211465. 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 HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform?

HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform is a medical device that received FDA 510(k) clearance on 2021-07-08. The listed applicant is Edwards Lfesciences. The 510(k) number is K211465.

When did HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform receive FDA 510(k) clearance?

HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform received FDA 510(k) clearance on 2021-07-08, under 510(k) number K211465.

Who is the listed applicant for HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform?

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

What is the FDA product code for HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform?

The FDA product code for HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform is DQK.

相關臨床試驗

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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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