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FDA 510(k)

HemoSphere先進監控平台，HemoSphere ForeSight血氧計纜線

K 號：K223127 · 2022-11-07

申請人Edwards Lifeciences, LLC
決定日期2022-11-07
產品代碼DQK
諮詢委員會履歷
決定相當於

器材摘要

HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifeciences, LLC. It received FDA 510(k) clearance on 2022-11-07 under 510(k) number K223127. 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 Monitoring Platform, HemoSphere ForeSight Oximeter cable?

HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable is a medical device that received FDA 510(k) clearance on 2022-11-07. The listed applicant is Edwards Lifeciences, LLC. The 510(k) number is K223127.

When did HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable receive FDA 510(k) clearance?

HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable received FDA 510(k) clearance on 2022-11-07, under 510(k) number K223127.

Who is the listed applicant for HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable?

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

What is the FDA product code for HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable?

The FDA product code for HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable is DQK.

相關臨床試驗

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其他以 Edwards Lifeciences, 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。

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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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