FDA 510(k)

A8, A9 麻醉系統

K 號：K201957 · 2021-03-26

申請人Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

決定日期2021-03-26

產品代碼BSZ

諮詢委員會AN

決定相當於

器材摘要

A8, A9 Anesthesia System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2021-03-26 under 510(k) number K201957. The device is classified under product code BSZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the A8, A9 Anesthesia System?

A8, A9 Anesthesia System is a medical device that received FDA 510(k) clearance on 2021-03-26. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K201957.

When did A8, A9 Anesthesia System receive FDA 510(k) clearance?

A8, A9 Anesthesia System received FDA 510(k) clearance on 2021-03-26, under 510(k) number K201957.

Who is the listed applicant for A8, A9 Anesthesia System?

The FDA 510(k) record lists Shenzhen Mindray Bio-Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A8, A9 Anesthesia System?

The FDA product code for A8, A9 Anesthesia System is BSZ.

其他以 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. 為申請人之記錄

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相關器械（代碼：BSZ）

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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