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FDA 510(k)

CoVa 監控系統 2

K 號:K160899 · 2017-06-22

申請人Tosense, Inc.
決定日期2017-06-22
產品代碼MWI
諮詢委員會履歷
決定相當於

器材摘要

CoVa Monitoring System 2 is the device name listed in this FDA 510(k) record. The listed applicant is Tosense, Inc.. It received FDA 510(k) clearance on 2017-06-22 under 510(k) number K160899. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CoVa Monitoring System 2?

CoVa Monitoring System 2 is a medical device that received FDA 510(k) clearance on 2017-06-22. The listed applicant is Tosense, Inc.. The 510(k) number is K160899.

When did CoVa Monitoring System 2 receive FDA 510(k) clearance?

CoVa Monitoring System 2 received FDA 510(k) clearance on 2017-06-22, under 510(k) number K160899.

Who is the listed applicant for CoVa Monitoring System 2?

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

What is the FDA product code for CoVa Monitoring System 2?

The FDA product code for CoVa Monitoring System 2 is MWI.

相關臨床試驗

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相關器械(代碼:MWI)

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。

官方來源

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