FDA 510(k)

C50及C80多參數病人監護儀

K 號：K191106 · 2019-12-13

申請人Shenzhen Comen Medical Instruments Co.,Ltd

決定日期2019-12-13

產品代碼MHX

諮詢委員會履歷

決定相當於

器材摘要

C50 and C80 Multi-parameter Patient Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Comen Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K191106. 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 C50 and C80 Multi-parameter Patient Monitor?

C50 and C80 Multi-parameter Patient Monitor is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is Shenzhen Comen Medical Instruments Co.,Ltd. The 510(k) number is K191106.

When did C50 and C80 Multi-parameter Patient Monitor receive FDA 510(k) clearance?

C50 and C80 Multi-parameter Patient Monitor received FDA 510(k) clearance on 2019-12-13, under 510(k) number K191106.

Who is the listed applicant for C50 and C80 Multi-parameter Patient Monitor?

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

What is the FDA product code for C50 and C80 Multi-parameter Patient Monitor?

The FDA product code for C50 and C80 Multi-parameter Patient Monitor is MHX.

其他以 Shenzhen Comen Medical Instruments 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。

K250854多參數病人監護儀（N10）；多參數病人監護儀（N12）；多參數病人監護儀（N15）；多參數病人監護儀（N10MPro）；多參數病人監護儀（N12MPro）；多參數病人監護儀（N15MPro）K250190連續壓縮系統（SCD600）K211619多參數病人監護儀 K173454多參數病人監護儀，型號C30

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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