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FDA 510(k)

731 系列呼吸機

K 號:K162832 · 2017-08-02

決定日期2017-08-02
產品代碼CBK
諮詢委員會AN
決定相當於

器材摘要

731 Series Ventilators is the device name listed in this FDA 510(k) record. The listed applicant is ZOLL Medical Corporation. It received FDA 510(k) clearance on 2017-08-02 under 510(k) number K162832. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 731 Series Ventilators?

731 Series Ventilators is a medical device that received FDA 510(k) clearance on 2017-08-02. The listed applicant is ZOLL Medical Corporation. The 510(k) number is K162832.

When did 731 Series Ventilators receive FDA 510(k) clearance?

731 Series Ventilators received FDA 510(k) clearance on 2017-08-02, under 510(k) number K162832.

Who is the listed applicant for 731 Series Ventilators?

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

What is the FDA product code for 731 Series Ventilators?

The FDA product code for 731 Series Ventilators is CBK.

相關臨床試驗

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其他以 ZOLL Medical Corporation 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。

相關器械(代碼:CBK)

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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