FDA 510(k)

VS 8 項生命徵監測儀，VS 8A 項生命徵監測儀，VS 9 項生命徵監測儀

K 號：K221267 · 2022-12-15

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

決定日期2022-12-15

產品代碼MWI

諮詢委員會履歷

決定相當於

器材摘要

VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.. It received FDA 510(k) clearance on 2022-12-15 under 510(k) number K221267. 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 VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor?

VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor is a medical device that received FDA 510(k) clearance on 2022-12-15. The listed applicant is Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.. The 510(k) number is K221267.

When did VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor receive FDA 510(k) clearance?

VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor received FDA 510(k) clearance on 2022-12-15, under 510(k) number K221267.

Who is the listed applicant for VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor?

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

What is the FDA product code for VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor?

The FDA product code for VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor is MWI.

其他以 Shenzhen Mindray Bio-Meidcal Electronics Co., 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。

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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。

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