FDA 510(k)

Passport系列病人監護儀（包括Passport 8、Passport 12）

K 號：K153448 · 2016-03-03

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

決定日期2016-03-03

產品代碼MHX

諮詢委員會履歷

決定相當於

器材摘要

Passport Series Patient Monitors (Including Passport 8, Passport 12) 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 2016-03-03 under 510(k) number K153448. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Passport Series Patient Monitors (Including Passport 8, Passport 12)?

Passport Series Patient Monitors (Including Passport 8, Passport 12) is a medical device that received FDA 510(k) clearance on 2016-03-03. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K153448.

When did Passport Series Patient Monitors (Including Passport 8, Passport 12) receive FDA 510(k) clearance?

Passport Series Patient Monitors (Including Passport 8, Passport 12) received FDA 510(k) clearance on 2016-03-03, under 510(k) number K153448.

Who is the listed applicant for Passport Series Patient Monitors (Including Passport 8, Passport 12)?

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 Passport Series Patient Monitors (Including Passport 8, Passport 12)?

The FDA product code for Passport Series Patient Monitors (Including Passport 8, Passport 12) is MHX.

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：MHX）

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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