FDA 510(k)

Cocoon 選向加熱系統

K 號：K181671 · 2019-05-02

決定日期2019-05-02

產品代碼DWJ

諮詢委員會履歷

決定相當於

器材摘要

Cocoon Convective Warming System is the device name listed in this FDA 510(k) record. The listed applicant is Care Essentials Pty, Ltd.. It received FDA 510(k) clearance on 2019-05-02 under 510(k) number K181671. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cocoon Convective Warming System?

Cocoon Convective Warming System is a medical device that received FDA 510(k) clearance on 2019-05-02. The listed applicant is Care Essentials Pty, Ltd.. The 510(k) number is K181671.

When did Cocoon Convective Warming System receive FDA 510(k) clearance?

Cocoon Convective Warming System received FDA 510(k) clearance on 2019-05-02, under 510(k) number K181671.

Who is the listed applicant for Cocoon Convective Warming System?

The FDA 510(k) record lists Care Essentials Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cocoon Convective Warming System?

The FDA product code for Cocoon Convective Warming System is DWJ.

其他以 Care Essentials Pty, Ltd. 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。

K232502Cocoon 過濾加熱系統，型號 CWS7000 K213907CareGUARD 過濾包

相關器械（代碼：DWJ）

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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